European Medical Devices Observatory
The European Medical Devices Observatory aims to collect the most significant news and information related to the implementation of EU Reg. 2017/745 (so-called MDR) in order to assist operators in complying with the new legislation.
MDCG 2021-20: Instructions for generating CIV-ID for MDR Clinical Investigations
The purpose of this MDCG is to provide instructions for the generation of the CIV-ID code for clinical investigations on Eudamed. The purpose of obtaining such a code is to allow identification of individual clinical investigations in order to facilitate relations between sponsors and competent authorities.
MDCG 2021-19: Guidance note integration of the UDI within an organisation’s quality management system
The purpose of this MDCG is to provide guidance on the integration of the UDI system and the implementation of UDI obligations as part of the companies' quality management system as set out in Art. 10.9 MDR and 10.8 IVDR.
Eudamed: modules "Devices" and "Certificates" are now available
Two more modules of the EUDAMED registration platform are officially operational. In particular, the modules related to marketed medical devices and to medical devices certificates issued by European Notified Bodies have been implemented. These modules are added to the already active one concerning the economic operators.
Please note that currently, the registration in Eudamed of the information required by Regulation 2017/745 is still optional.
MDCG 2021-18: Application form - codes associated with IVDs to be attached to the application under MDCG 2021-16
This MDCG contains the form to choose the codes associated with in vitro medical device categories, to be attached to the application included in MDCG 2021-16.
MDCG 2021-17: Application form - codes associated with MDs to be attached to the application under MDCG 2021-15
This MDCG contains the form to choose the codes associated with the medical device categories, to be attached to the application included in MDCG 2021-15.
MDCG 2021-16: Application form to be submitted by a conformity assessment body when applying for designation as NB under the IVDR
This MDCG contains the form to apply for the designation as a notified body under the In Vitro Diagnostic Regulation.
MDCG 2021-15: Application form to be submitted by a conformity assessment body when applying for designation as NB under the MDR
This MDCG contains the form to apply for the designation as notified body under the Medical Devices Regulation.
MDCG 2021-14: Explanatory note on IVDR codes
Implementing Regulation 2017/2185 provides a list of codes to which different types of medical devices and in vitro diagnostic medical devices correspond. These codes make it easier to identify the scope of competence of individual notified bodies. The purpose of this MDCG is to illustrate how the IVDR codes should be used.
Swiss authorised representative (CH-REP)
Due to the non-renewal of the agreement between Switzerland and the European Union on the mutual recognition of conformity certificates (Mutual Recognition Agreement, MRA), Switzerland is currently considered a third country under Regulation 2017/745. Therefore, all manufacturers wishing to market medical devices in Switzerland must comply with the national regulations in force here and in particular appoint a Swiss Authorised Representative.
The document clarifies which symbol should be used on the product packaging to indicate the name of the Swiss authorised representative.
Q&A for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the MDR and IVDR
The document intends to provide answers to a number of questions on issues under EMA competence, which should also be read in light of the provisions of Reg. 2017/745 and/or Reg. 2017/746. In particular, it considers: 1) MDs that contain a medicinal product as an integral part; 2) medicinal products that include a MD in the secondary packaging; 3) the consultation procedure for ancillary medicinal substances that are an integral part of a MD. The document is mainly addressed to applicants and/or marketing authorisation holders of medicinal products and Notified Bodies.
Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
In view of the full applicability of Regulation 2017/746, the document aims to establish what are the priorities and concrete actions to be undertaken by Member States, the European Commission and all stakeholders.
These priorities are divided into two categories: Set A, which includes actions that are essential for medical devices to concretely have access to the European market; Set B, which includes all those documents that will be published to facilitate the compliance of economic operators.
MDCG 2021-12: FAQs on the European Medical Device Nomenclature (EMDN)
The MDCG has published a series of questions and answers on the new European nomenclature system EMDN, to be used in particular for the registration of medical devices in EUDAMED. In particular, the document clarifies what the EMDN system is, what principles govern it, how to access it and how the nomenclature is structured.
MDCG 2021-11: Guidance on Implant Card – ‘Device types’
Art. 18(a) MDR states that the manufacturer of implantable MDs must include an impant card with the device, i.e. a document where information about the implanted MD is reported to allow its identification, including the "Type of device", as provided by the MDCG Guide 2019-8. This 2021-11 Guidance, therefore, is intended to provide a non-exhaustive list of examples of implantable medical "Device Types" to assist the manufacturer in identifying the appropriate terms to include on the Implant Card.
MDCG 2021-10: The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
The Guidance includes guidance on how to interpret in the light of the MDR/IVDR some of the principles and examples included in Annexes E to I of the IMDRF - UDI System Application Guide. The objective of this document is to provide details and specifications necessary to ensure a harmonised use of the requirements included in the further IMDRF UDI Guidance Document.
The Annexes covered by the Guidance are the following: Examples of UoU and packaging configurations; Feasibility issues linked to direct marking integrity; Kit Examples; Examples of changes to configurable medical devices; Example of UDI assignment for software.
MDCG 2021-9: Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
Reg. 2017/745 in Article 27 introduces the UDI system, whose function is, among others, to enable product identification and to allow the implementation of effective post-market surveillance systems. In this context, the Guidance provides (provisional) guidance for the implementation of the UDI system and related activities for specific products, such as contact lenses, eyeglasses, prescription lenses and reading glasses.
MDCG 2021-8: Clinical investigation application/notification documents
With regard to clinical investigations of medical devices, the document provides a set of templates that, pending the full operation of the EUDAMED system, must be completed and submitted to the competent authorities of the Member State where the investigation will be conducted.
However, it is noted that these templates will be withdrawn and therefore will no longer be usable as soon as the EUDAMED clinical investigation module is operational.
MDCG 2021-7: Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 IVDs
17 May 2021
The MDCG has published a notice regarding in vitro diagnostic medical devices intended to detect and/or quantify markers of SARS-CoV-2 infection. In this notice, manufacturers and authorised representatives of such devices are reminded that it is necessary to continuously assess the impact of new variants of the SARS-CoV-2 virus on their medical devices to ensure compliance with essential requirements, patient safety, a high level of performance, and overall compliance with the IVDR.
EU Commission Implementation Model for Medical Devices Regulation
The European Commission has published a short step-by-step guide for the implementation of the MDR in manufacturing a medical device. The guide presents a clear picture of what activities are needed to be compliant with the Regulation and in what order they should be carried out.
EU Commission Factsheet for implantable medical devices
A new factsheet has been published with a focus on the implant cards that manufacturers of implantable medical devices must make and deliver to the patient. The document contains the information that must be provided to the patient and a template of an implantable card, as well as some useful Q&As.
EU Commission Factsheet for Class I medical devices
The European Commission has produced a new Factsheet entitled "What You Need to Know About Regulation (EU) 2017/745" containing a useful outline for understanding the steps to follow when placing Class I MDs on the market and a Q&A on the transition period ex art. 120, the instructions for use, the language of the labelling, and the qualification of medical devices accessories.
MDCG 2018-1 rev. 4: Guidance on BASIC UDI-DI and changes to UDI-DI
27 April 2021
The MDCG has published an update to the guide on the functioning of the UDI system. In particular, it aims to provide a clarification of the concept of the Basic UDI, its use in technical documentation, and the elements that determine the need to change the device model identification number (UDI-DI).
MDCG 2021-6: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
22 April 2021
The MDCG has published a new guide containing Questions & Answers on clinical investigations, which clarify a number of interesting points, such as the difference between performance, clinical performance and clinical benefit or what the safety reporting requirements are.
In particular, it provides an outline clarifying the possible clinical investigations to be carried out (on CE-marked MDs, on non-marked MDs, and on MDs that will not be marked) and a (non-exhaustive) list of changes to the investigation that should be considered "substantial" under Art. 75 MDR.
MDCG 2021-4: Application of transitional provisions for certification of class D IVDs according to Reg. (EU) 2017/746
EU Reg. 2017/746 establishes that for the conformity assessment of Class D in vitro medical devices, the manufacturer must request the involvement of a Notified Body and, under certain conditions, of a panel of experts and/or an EU reference laboratory to carry out the specific tests required by law.
The Guidance provides some guidance on the application in the transitional period (until 26 May 2022) of the rules of Regulation 2017/746 with regard to expert panels and EU reference laboratories (EURLs).
MDCG 2021-5: Guidance on standardisation for medical devices
19 April 2021
The MDCG has published new guidance on the procedures for issuing harmonised standards and on their compliance. In particular, it confirms the principle that mere conformity with the most recent version of a harmonised standard - whose reference is not listed in the OJEU - does not automatically imply compliance with the requirements of the applicable EU legislation, unless further evidence of safety and effectiveness is produced in the technical documentation.
Eurofins Expert Services Oy: new Notified Body
7 April 2021
Eurofins Expert Services Oy is a new Notified Body according to the Regulation 2017/745 (MDR). To date, there are approved 20 Notified Bodies under the MDR.
EU Commission publishes infographic on medical device software qualification
Determining when software should be qualified as a medical device and therefore fall under the scope of EU Reg. 2017/475 and when it should not, is particularly relevant from a legal but also practical point of view. The European Commission's Directorate-General for Health and Food Safety has recently produced an infographic with the intention of illustrating the decision-making steps and helping the manufacturer in qualifying software as a medical device.
MDCG 2021-3: Questions and Answers on Custom-Made Devices
16 March 2021
The MDCG has published new guidance on custom-made medical devices. In particular, the document analyses the differences between custom-made, adaptable and patient-matched medical devices. It also clarifies which obligations must be fulfilled by the manufacturer of a custom-made medical device (or its parts), what is meant by 'written prescription of a healthcare professional' and what are the conditions for a 3D medical device to qualify as a custom-made.
New guidance on classification principles for in vitro medical devices (IVDs) by IMDRF
5 March 2021
The IMDRF has published new guidance aimed at encouraging the global market to converge into a single regulatory system. In particular, the guidance is useful for IVD manufacturers to determine the risk class of their in vitro medical devices based on their intended use.
Italian National Institute of Health: new Notified Body for MDR and IVDR purposes
16 February 2021
The Istituto Superiore di Sanità has been designated as a new Notified Body according to the Regulation 2017/745 (MDR). To date, there are 19 Notified Bodies accredited according to the MDR.
Remote audit for the evaluation of quality management systems
11 January 2021
As part of the procedure for the assessment of the manufacturer's quality management system, the European Commission has authorised Notified Bodies to carry out the audits required by Annex IX, points 2.3 and 3.3 MDR and IVDR remotely (and no longer solely on-site). This is only for as long as the health emergency persists, provided it is justified by concrete circumstances and the respective competent authorities have been informed.
SGS FIMKO OY: new Notified Body
SGS FIMKO OY is a new Notified Body under Regulation 2017/745 (MDR). To date, there are 18 Notified Bodies approved under the MDR.
MDCG 2020-18: Position Paper on UDI assignment for Spectacle lenses & Ready readers
The MDCG Guide 2020-18 explains in detail how manufacturers of ophthalmic lenses and reading glasses (so-called Ready Readers) are to apply the UDI code. To this end, Annexes I (called Spectacle lenses) and II (called Ready Readers) specify the data that must be included in the UDI code.
New Notified Body: UDEM Adriatic D.O.O.
New Notified Body: UDEM Adriatic D.O.O.
MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The MDCG Guide 2020-16 details the classification rules for in-vitro medical devices and provides useful practical examples for better understanding.
Regulation (EU) 2017/746 establishes that in-vitro medical devices are divided into classes A, B, C and D according to the intended use of the device and the risks associated with its use (see art. 47).
The European Commission publishes FAQs on the UDI system
The European Commission has recently published a document containing the most relevant FAQs on UDI, the unique identification system for medical devices, updated to Reg. 2017/745 on medical devices and Reg. 2017/746 on in vitro diagnostic medical devices.
Checklist on Instructions for Use for reusable and resterilisable medical devices
28 July 2020
The European Commission has published a document by the Compliance and Enforcement Group (COEN) to address frequent non-compliance of the instructions for use of resterilisable medical devices. The document also contains a checklist for the Instructions for Use (IFU), based on ISO 17664 and a checklist for the evaluation of the validation of the reprocessing of reusable medical devices, based on ISO 14937.
MDCG 2020-13: Clinical evaluation assessment report template
The Clinical Evaluation Assessment Report (CEAR) is a report used by the Notified Body to document the conclusions of its assessment with regard to the clinical evidence presented by the manufacturer. The MDCG-13 Guide clarifies how to compile the CEAR and provides a template with the minimum information that must be incorporated into the processes and procedures of the Notified Body.
Q&A on conformity assessment procedures for protective devices
8 July 2020
The document refers to manufacturers of protective equipment, such as masks and gloves, which are in particular demand in the current health crisis, and answers the main questions about conformity assessment procedures.
List of COVID-19 essential Medical Devices (MDs and IVDs)
8 July 2020
The European Commission has published a document containing the list of essential medical devices and in vitro medical devices in the COVID-19 epidemic. The table provides a definition of the device,as well as the EMDN (European Medical Device Nomenclature) and CND (National Classification of Medical Devices) nomenclature.
MDCG 2020-12: Transitional provisions on devices incorporating a substance which may be considered a medicinal product
10 June 2020
Under Directive 93/42/EEC (MDD), Annex I, Sec. 7.4, and Reg. 2017/745 (MDR), Art. 52(9), as regards medical devices incorporating substances, which if used independently would be qualified as medicinal products ex Reg. 2001/83, and which perform an ancillary function with respect to that of the medical device (i.e. not the main function), NBs must consult the Competent Authority for medicinal products in the relevant Member State on the adequacy and safety of the substance itself. The MDCG 2020-12 explains how to fulfill this obligation according to the MDR, when such consultation has already taken place for that same medical device under the MDD.
COVID-19: General information to verify PPE and DM compliance
25 May 2020
The European Commission has published a document in which it answers some of the most frequently asked questions by subjects who have to purchase and place personal protective equipment or medical devices on the EU market during COVID-19 and have trouble determining whether a product complies with the applicable legislation.
EU Commission guidelines on Union-level derogations for medical devices
20 May 2020
Both Directive 93/42/EEC and Regulation 2017/745 provide that Member States may introduce national derogations for the marketing of DM of interest for public health, safety and health of patients, but for which the conformity assessment procedures have not been fully completed. In exceptional cases, the Commission may extend the validity of this derogation to the whole territory of the Union. This Commission Communication sets out the principles to be followed in this case, the procedure and the general conditions.
MDCG 2020-10: Reporting of adverse events during clinical investigations
15 May 2020
MDCG Guideline 10/2020, acknowledging that the electronic system referred to in Article 73 (Eudamed) will not be operational on the date of application of the MDR (26 May 2021), provides all instructions to be followed by sponsors in the event of adverse event reports emerging during an investigation. The Guideline will apply to both Pre Marketing clinical investigations and Post Marketing Clinical Follow up investigations. The Guideline is divided into two parts: part 1 contains the application guidelines, while part 2 contains the safety reporting scheme.
MDC Medical Device Certification GMBH is a new notified body under the MDR
25 April 2020
A new Notified Body has recently been designated under the MDR. It is the German body MDC Medical Device Certification GMBH. The total number of Notified Bodies for MDR certifications now rises to 13.
COVID-19: MDCG 2020-9 on solutions to meet the demand for ventilators and related accessories
24 April 2020
Due to the COVID-19 global health crisis, there has been an exponential increase in demand for ventilators and related accessories needed to fight the pandemic. In order to meet this growing demand, the MDCG 2020-9 outliens several regulatory options for the facilitated placing on the market of these devices and the related procedure.
MDCG 2020-6: clinical evidence required for equivalent devices
24 April 2020
Paragraph 6a of Article 61 MDR introduces an exception to the manufacturer's obligation to possess sufficient clinical evidence to demonstrate the conformity of his MD to GSPRs (Annex I) for all implantable devices and Class III devices that have already been legally placed on the market or put into service under Directive 93/42/EEC (so called legacy devices).
The purpose of the new MDCG Guide 2020-6 is to explain how to collect sufficient clinical evidence to demonstrate the mentioned compliance for legacy devices that are already CE marked according to Dir 93/42/EEC and therefore benefit from the exemption of paragraph 6. It also provides recommendations for conducting clinical evaluations for legacy devices listed in Annex XIV, Part A of the MDR.
MDCG 2020-5: Clinical Evaluation - Equivalence, a guide for manufacturers and notified bodies
24 April 2020
As part of the conformity assessment, Reg. 745/2017 (MDR) provides for the possibility to carry out the clinical evaluation of a MD using clinical data referred to an "equivalent device". To carry out this particular type of clinical evaluation under Directive 94/42/EEC, reference should be made to the MEDDEV Guide 2.7/1 rev. 4, which however is not fully aligned with the requirements of the new Regulation.
The aim of the MDCG 2020-5 is therefore to explain the differences in technical, biological and clinical criteria existing between the two systems in order to demonstrate that two MDs can be considered "equivalent".
MDCG Guide 2020-8: PMCF Evaluation Report Template
23 April 2020
The manufacturer, in accordance with Regulation 745/2017, must put in place a post-market follow up plan (PMCF) of the device placed on the market. Annex XIV, Part B, requires the manufacturer to evaluate the results of this PMCF through an evaluation report. The MDCG Guide 2020-8 provides for this purpose a template for an assessment report that the manufacturer can use in his activities.
MDCG 2020-07: PMCF Plan Template, a guide for manufacturers and notified bodies
23 April 2020
The manufacturer, in accordance with Regulation 745/2017, must put in place a post-market clinical follow up plan (PMCF) of the device placed on the market. In particular, Annex XIV, Part B, states that this surveillance must be carried out according to a documented method, established in a PMCF plan. MDCG 2020-7 therefore provides a template for a regulatory compliant PMCF plan, which the manufacturer may use in its business.
Regulation 2020/561 which postpones the application of Regulation 2017/745 (MDR) by one year is in force
23 April 2020
The postponement of EU Reg. 2017/745 on medical devices by one year is official. Reg. 2020/561 postponing its application was published in the Official Journal of the European Union and states in recital 5 that in light of the COVID-19 epidemic and the additional resources needed for Member States, health institutions and economic operators, the application of the provisions of the Regulation is postponed by one year.
Update of MDCG 2019-3 on Article 54.2(b)
3 April 2020
Article 54.2 of Regulation 745/2017 establishes that the Notified Body must not carry out the clinical evaluation consultation for certain specific medical devices, including, under certain conditions, those made by making changes to a device already marketed by the same manufacturer for the same intended use. MDCG Guide 2019-3 already included the interpretation of this provision. Now, following the recent revision, it also sets out the procedural aspects to be respected in order to benefit from the exemption under Article 54.2(b).
Guidance on medical devices, active implantable and in vitro diagnostic medical devices in the COVID-19 context
3 April 2020
The European Commission has recently published a document in which it carefully examines the rules to be complied with for the placing on the market of medical devices, active implantable medical devices and in vitro medical devices and, in particular, because of the current health emergency, it determines which possible exemptions can be used by the manufacturer.
COVID-19: comparative chart of DM regulatory differences worldwide
3 April 2020
Due to the Covid-19 health emergency, the import/export of medical devices needed to deal with the emergency has increased exponentially. The IMDRF has published a chart comparing different DM legislation around the world to highlight differences and similarities.
A proposal to postpone Regulation 745/2017 has been published
3 April 2020
Due to the enormous challenges posed by the COVID-19 and the ongoing health emergency, the European Commission has published a proposal to postpone Regulation 745/2017 by one year. If the proposal is approved, this legislation will become fully effective from May 26, 2021 (instead of May 26, 2020, as originally foreseen).
Drug devices combination products – Guide to Art. 117 MDR
1 April 2020
Article 1(8) of the MDR provides that if a medical device incorporates a substance which, if used separately, would be considered a medicinal product according to Dir. 2001/83/EC, it must be placed on the market in accordance with the MDR. Article 117(2) then states that if the MDR dossier does not include the results of the conformity assessment of the device part with the relevant General Safety and Performance Requirements (GSPR - Annex I) and if the intervention of a NB is required for the conformity assessment, the Authority requires the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements (GSPR). The NB Team has recently published a document providing useful guidance on the structure and content and format of such opinion.
COVID-19 e conformity assessment procedures for 3d printing and 3d printed products
1 April 2020
The document lists which harmonised technical standards can be followed in the conformity assessment procedure for 3D printing products. In addition, it states that 3D printed products used in the medical field must comply with the relevant legislation on medical devices (Directive 93/42/EEC and subsequent Regulation 745/2017) and then some specifications for proper marketing are explained.
Proposal to postpone by one year the application of the MDR
25 March 2020
The European Commission is working on a proposal to postpone by one year the date of application of the EU Regulation 2017/745 on medical devices due to the COVID-19 emergency, due to the fact that medical devices companies are fully engaged in the fight against COVID-19, thus preventing them from effectively reaching compliance with the MDR until 26 May 2020. The proposal should be received by the beginning of April.
MedTech Europe calls for a pause on MDR and IVDR implementation
23 March 2020
MedTech Europe, the European association representing medical and diagnostic device manufacturers, in light of the extraordinary efforts being made by medical device companies during the COVID-19 outbreak, has asked for an extension of the implementation of the MDR and IVDR Regulations. The proposed timeframe is six months after the end of the health crisis.
Clinical evaluation of medical device software
17 March 2020
Manufacturers of medical device software (MDSW), which have a clinical benefit, need clinical evidence to carry out the clinical evaluation of the DM according to Regulation 745/2017. The recent MDCG Guide 2020-1 provides a framework useful to determine the level of clinical evidence required for the clinical evaluation of your MDSW. In particular, in Annex 1 the Guide proposes an diagram with some methodological principles useful to obtain the necessary clinical evidence and in Annex 2 some examples of how to carry out a correct clinical evaluation. The Guide should be integrated with the indications contained in other documents on clinical evaluation (i.e. for all medical devices). In addition, the manufacturer may refer to MDCG 2019-11 in order to assess the correct qualification and classification of his MDSW.
Class I MDs - Conditions to benefit from the transitional period pursuant to Art. 120
16 March 2020
The MDCG 2020-2 explains what conditions should be met for a Class I device in order to continue to be placed on the market in accordance with Directive 93/42/EEC, even after 26 May 2020. Particular attention is given to the declaration of conformity, which must be drawn up in accordance with Directive 93/42/EEC strictly before 26 May 2020.
Guide for the interpretation of "significant changes" under Article 120 MDR
16 March 2019
Article 120 MDR lays down the conditions to fulfill in order to lawfully continue to market DM which comply with Directive 93/42 after 26 May 2020. One of such conditions is that no "significant changes" should be made to the MD. The Commission has therefore issued a document with 6 flowcharts which should be used by the manufacturer in order to determine if a change is "significant" for the purposes of article 120(3) and therefore prevents the manufacturer from continuing to market the MD in accordance with Directive 93/42/EEC. In particular, the first flowchart is of a general nature, while those from A to E are specific for the type of change made: change of the intended use (A); change of the design or performance (B); change of the software (C); change of the material (D); change of the sterilization method or of the packaging (if it affects sterilization).
Priorities plan of the European Commission
11 March 2020
A joint action plan of the European Commission and the Member States has been published, which defines what concrete actions should be taken as a priority in the field of medical devices in order to have an operational system from May 2020, the date of entry into force of Regulation 745/2017. The plan mainly concerns: EUDAMED; ensuring the placing on the market of safe MDs; clinical evaluation and Expert Panel; other important implementing acts.
Template for the EU declaration of conformity
17 February 2019
The European Commission had published a template for the EU declaration of conformity in accordance with Directive 2014/68/EU. This template may be used as an example by the Manufacturer of medical devices in order to draw up the EU declaration of conformity required by Regulation 745/2017 in article 19 MDR, provided that any reference to Directive 2014/68/EU is deleted and any relevant information is changed or added. Thus, the declaration so drafted should be periodically updated and kept available for 10 years after the last device covered by it had been placed on the market (15 years in case of implantable devices).
Two new Notified Bodies, one of which is the first non-EU NB
17 February 2019
The list of Notified Bodies accredited according to the Regulation 745/2017 has recently been updated with the introduction of National Standards Authority of Ireland (NSAI) and DNV GL Presafe. The peculiarity of the latter is the fact that DNV is established in Norway, which belongs to the EEA (European Economic Area), but not to the European Union. DNV GL Presafe, therefore, qualifies as the first "non-European" NB.
Brexit and MD: Guidance for manufacturers on clinical investigations of medical devices
25 January 2020
The MHRA has recently updated the Guidance for manufacturers on clinical investigations of medical devices conducted in the UK and therefore aimed at being placed on the UK market. Such investigations are sometimes required to demonstrate that the DM produced complies with the relevant essential requirements set forth in the European Directives and therefore with the relevant UK legislation (Medical Device Regulation 2002 as last amended in 2019). The Guide explains in detail the steps to be followed in conducting the clinical investigation and the role of the MHRA in the process. The very fact, however, that the MHRA updated this document by referring only to the Directives and not also to the Regulation, could be interpreted as a sign that a Hard Brexit on MD is getting closer.
Schedule of MDCG and its subgroups meetings in 2020
23 January 2020
The MDCG and its subgroups meetings calendar for 2020 has been published. It is thus possible to see what the EU will be focusing on in the coming months. In particular, there are 4 meetings on pre- and post-market surveillance. As the date of the Regulation's full operation approaches, the activity of the MDCG intensifies.
The Italian CND has been chosen as the basis for the implementation of the EMDN
10 January 2020
It was announced that the National Medical Device Classification (CND) (the Italian classification that divides MDs into homogeneous categories of products) will be the basis for the creation of the European Medical Device Nomenclature (EMDN), the new nomenclature to be used for the registration in EUDAMED of any produced medical device. The document also provides further information on the characteristics of this nomenclature system. The European Commission has therefore also prepared a document which explains the basic principles and functioning of the CND.
Cybersecurity and medical devices
07 January 2020
Regulation 745/2017 in Annex I establishes that manufacturers of medical devices incorporating programmable electronic systems, including software, and/or software that are themselves medical devices should comply with specific essential security requirements and take into account the state-of-the-art in information security, IT security, access restriction, etc. The MDCG 2019-16 guide provides the manufacturer (and also some other economic entities) with useful guidance on definitions of IT security concepts, how to comply with regulatory requirements and how to demonstrate such compliance, throughout the life of the device. It also contains numerous examples of information security incidents.
Class I medical devices - the new Guidelines for manufacturers
17 December 2019
The Medical Device Coordination Group has recently published new Guidelines for manufacturers of those MDs classified in class I both under Directive 93/42/EEC and the new Regulation 745/2017. This document provides a detailed explanation of all the steps necessary to properly place on the market this type of MDs. Moreover, it lists and clarifies everything the manufacturer needs to know, from how the correct identify the nature of the device to the requirements for the implementation of the post-market surveillance.
New Notified Bodies have been designated - "only" 11 left
16 December 2019
MEDCERT and DEKRA Certification B.V. are the last Notified Bodies to be designated under the new MDR. Therefore, up to now the total amount of NB is 9, unfortunately way below the threshold of 20 required by the Regulation. The complete list is available on the NANDO web site. New notification procedures are expected soon, in order to enable manufacturers to fully comply with their obligations under the new Regulation.
The new Guidance on sampling of Class IIa and IIb MDs
11 December 2019
The Medical Device Coordination Group has prepared a useful guide to assess the criteria to be respected in the selection of representative samples of class IIa and IIb MDs. In particular, sampling is necessary to evaluate the clinical documentation required by the new Regulation and is used by the NBs to prepare the sampling plan.
10% VAT (IVA) for substance-based MDs, but only if classifiable under heading 3004
10 December 2019
In its reply to question 507 - 10th of December 2019, the Italian Revenue Agency (Agenzia delle Entrate) established that 10% VAT also applies to medical devices based on substances used for medical treatment, disease prevention and medical and veterinary treatment, but only if they are classifiable under heading 3004 of the Combined Nomenclature. However, an agreement on the interpretation of what falls within heading 3004 is far from being reached. The decision on the classification of a product falls within the exclusive competence of the Customs and Monopolies Agency (Agenzia delle dogane e dei monopoli), which will therefore have the final say in the matter.
Updated version of the new ISO 14971 - Risk Management and Assessment is now available
9 December 2019
ISO 14971: 2019 is a harmonised IVD and MD standard, with the aim to provide basic principles of the risk assessment and risk management process. It should be recalled that compliance with harmonised standards like the present one allows manufacturers to enjoy a presumption of conformity with Community legislation, as set forth in particular in Article 8 of the MDR Regulation. The new version replaces the 2012 version.
Class I medical devices (probably) postponed to May 2024
3 December 2019
The second Corrigendum to Regulation 745/2017 is currently being approved. Thanks to the changes introduced, it will be possible to continue placing on the market Class I medical devices under Directive 93/42/ECC until 26 May 2024, which would be in a higher class according to the new Regulation. The only condition applicable is that manufacturers should continue to comply with the previous Directive and with the new requirements on post-market surveillance, market surveillance, surveillance, registration of economic operators and devices set forth by the new Regulation. Moreover, there should not be any significant changes in the MD itself.
Towards the updating of the Blue Guide
28 November 2019
Another recent ambitious project of the European Commission is the updating of the so-called Blue Guide, aimed at including the innovations introduced by Regulations 2017/745 and 746 and the developments occurred over the years at international level. The Guide, published in 2000, was last updated in 2016 and provides an overview of European product regulations and it is therefore a valuable aid to European manufacturers in understanding and applying them.
EUDAMED: two-year delay confirmed
30 October 2019
The European Commission has confirmed a two-year delay for the implementation of EUDAMED. The MDRegulation established the introduction of this new database for medical devices in order to ensure a higher level of transparency and safety of the entire system and to monitor the medical devices’ level of performance. It will be fully operational in May 2022. This date coincides with the entry into force of the Regulation 746/2017 on in-vitro medical devices.
On the classification of software as medical devices - the new MDSW 2.1/6 Guide
11 October 2019
The latest revision of the Guide for the classification of software as medical devices has finally been published. Compared to the previous version (MEDDEV 2.1/6), the current Guide (MDCG 2019-11), updated to Regulations 745-746/2017, provides more specific definitions and practical examples. In view of the important changes made by the new Regulation to the classification of MDSW software, the Guide is an excellent ally to help manufacturers evaluate their software.
Revision of incident report form published - mandatory from January 2020
3 October 2019
The European Commission has published a revised form for the manufacturer's incident report. Using this form is mandatory as early as January 2020. Reporting incidents related to your medical device placed on the market is one of the obligations to comply with within the process of post-market surveillance.
Guide on the drafting of the Safety and Clinical Performance Summary for implantable and class III medical devices
26 September 2019
The new MDCG 2019-9 guides manufacturers of implantable or class III medical devices (excluding those custom-made and under investigation) in drafting the Summary of Safety and Clinical Performance. This document must be validated by a NB and published in the EUDAMED database. Moreover, the Guide analyses separately each mandatory point of the Summary according to Article 32 of the new Regulation and it provides specific examples of what should be included therein. The Guide also provides a fac-simile of the Summary itself.
The new figure of the Compliance Officer in Regulation 745/2017 - the MDCG Guide 2019-7 for manufacturers
20 June 2019
Regulation 745/2017 introduces a new figure within the medical devices company: the person responsible for compliance. This person, provided for in article 15, is close to an "internal guarantor” and it should be appointed by the manufacturer and any authorized representative. The new MDCG 2019-7 Guide aims to provide useful indications on the specific qualifications that this figure should have, his role and responsibilities within the company.
Article 54.2 (b) and the exemption from the pre-market clinical evaluation consultation procedure provided therein
Article 54 establishes the procedure to be followed in the pre-market clinical evaluation consultation. Paragraph 2, on the other hand, provides for some exemptions. In particular, according to letter (b), the above-mentioned consultation is not necessary whenever a medical device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose. Guide MDCG 2019-3 lays down some criteria in order to establish when a device may be said to be “already marketed” and therefore it tries to avoid doubts of interpretation.