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.
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.