Italian MDR harmonisation decree: clarifications for Notified Bodies and manufacturers

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It has been a very busy summer for the medical device sector. On 28 July, the Council of Ministers approved the Decree harmonising Italian law to the MDR in order to implement the European Delegation Law No. 53 of 22 April 2021. The decree has been published in the Official Gazette on 13 September 2022, so we are now able to discuss the areas it covers. Namely:

establishment of the contents, timeframes and modalities of the communication obligations for manufacturers, distributors and users to the Ministry of Health (i.e. registration in the database, communications for vigilance, etc.)
definition of the entire penalty system (which is considerably full-bodied);
identification of traceability methods for medical devices through the reorganisation and connection of existing Databases in accordance with the Unique Device Identification system (UDI);
reorganisation of the mechanism for defining expenditure ceilings;
improving purchasing procedures by articulating and strengthening Health Technology Assessment (HTA) functions and adjusting the activities of the Price Observatory for the purchase of devices.

Hence not only the new rules deriving from the MDR but also a new structure for deciding how to purchase and how much to spend. These issues now significantly intersect with the development of digital health (not only telemedicine but also Digital Therapeutics and digital support), promoted by the PNRR. It is no coincidence, then, that in July the latest issue of the Monitor magazine of Agenas (which now plays the role of National Agency for Digital Health as provided for by Law 28/2022) announced the establishment of an HTA working group specifically dedicated to digital health.

The relationship between Notified Bodies and manufacturers

In the meantime, 'adjustments' to the relationship between Notified Bodies (Nb) and manufacturers are being sought in the EU, in the realisation that, on the one hand, the number of Notified Bodies is low and many have become quite inflexible for fear of losing their notification. On the other hand, manufacturers are not sufficiently prepared for the transition to MDR and IVDR, possibly having underestimated the complexity of the work to be done. The concern seems to be about running out of devices and jeopardising the access of innovative medical devices to the European market. Thus, the long-awaited MDCG 2022-14, entitled Position Paper Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs, was recently published. The text is very comprehensive and though it will not solve everything, it will undoubtedly ease some of the issues.

Recommended actions

The MDGC proposes a series of actions aimed at improving the capacity of NBs, access to them and also the preparedness of manufacturers. Very briefly, the recommended actions are as follows:

increase the capacity of Notified Bodies
make use of hybrid audits if it deemed to speed up procedures while maintaining quality and efficiency;
leverage evidence from previous evaluations carried out within the framework of the Directives in relation to the requirements of the Directives, where these are considered relevant and appropriate for the Regulations as well;
carry out 'appropriate surveillance' on legacy devices (Art. 120 MDR), using to the full the flexibility previously described in MDCG 2022-4 (e.g. combination of audits on legacy devices under the Directives and the Regulations; focus on assessing compliance with MDR/IVDR requirements instead of surveillance of compliance with the requirements of the Directives etc.);
streamlining internal administrative procedures.

Simplification as an objective

In addition, the MDCG states that it intends to revise its guidelines in order to remove the administrative workload of Notified Bodies, to work within the development of Eudamed to ensure that the exchange of information takes place machine-to-machine, and to explore means to add codes to the designation of Notified Bodies (this will also greatly streamline the work when the new AI Regulation comes into force for those NBs that will also be accredited to certify AI systems).

Very interesting, also, is the passage stating that the guidelines issued by the MDCG are only guidance documents whose purpose is to provide a harmonised interpretation. It follows that since they are not coercive acts, a certain flexibility is allowed with regard to the manner in which compliance with legal requirements is demonstrated. In essence, the MDCGs are to be applied with understanding; with this in mind, it is argued that reasonable time must be allowed for the new guidelines to be incorporated. This means that the guidelines should not be applied to ongoing processes or applications already initiated by a manufacturer for conformity assessment, unless the application of the guidelines would lead to greater efficiency in the process.

Improving access to Notified Bodies...

In order to facilitate access to Nb (especially by SMEs), the Position Paper also insists that Nb make standard business rates publicly available (Article 50 MDR/Article 46 IVDR), and also encourages that published rates be easily comparable.

… and the preparedness of manufacturers

A very interesting section then states that in order to increase manufacturers' preparedness, Notified Bodies and manufacturers themselves are encouraged to organise structured dialogues before and during the conformity assessment process, where this is useful to improve the efficiency and predictability of the conformity assessment process, while respecting the notified body's independence and impartiality (an activity also admitted in Annex VI Section 1.2.9.). To clear away any doubts, it is also specified that such dialogues are not to be considered as consultancy services. Furthermore, the MDCG invites all parties involved to continue and, where possible, intensify communication with manufacturers through webinars, workshops, targeted feedback and information sessions. These are the working hypotheses:

NBs are invited to work on common guidelines to assist manufacturers, also in relation to typical non-conformities and in the preparation and content of technical documentation;
national authorities are invited to continue to promote awareness and engagement with stakeholders at national level and to exchange best practices on information campaigns among themselves;
trade associations are invited to promote and ensure economic operators' knowledge and awareness of the new regulatory framework.

Conformity assessments

Finally, the Position Paper indicates some actions that may facilitate the transition to MDR and IVDR. More specifically, in the MDCG it is considered, particularly with regard to safe and effective legacy devices, including ‘orphan devices’, that there is a need to reduce the complexity of conformity assessments and ensure greater pragmatism with regard to demonstrating compliance with applicable requirements. To this end, the MDCG seeks to undertake the following additional actions:

drafting further guidance to Nb's and manufacturers to facilitate the practical application of Article 61 MDR (clinical evaluation) and Article 56 IVDR (performance evaluation and clinical evidence), as well as to make appropriate use of the MDCG guidance on clinical evidence for legacy devices and clinical equivalence evaluation.
acknowledges the peculiar status of 'orphan devices' and states that it intends to work to provide a definition for them; it then suggests specific guidance or other means of assistance for these products so that they can meet legal requirements. It also states that sustainable medium- and long-term solutions for orphan devices must be developed.
urges Medicines Agencies (AIFA for Italy) to accept and process NBs assessments of medical devices incorporating an ancillary medicinal substance and companion diagnostics.

In this respect, these Agencies should ensure that in the case of devices already CE-certified under the Directives an expedited review is carried out according to the recommendation contained in MDCG 2020-12. The MDCG then invites the Directors of the Member States' Agencies as well as the EMA to take action to ensure that the consultations required for the purpose of affixing the CE marking under the Regulations take place in a timely and cost-efficient manner, in particular with regard to devices that have been submitted for consultation under MDD/AIMDD