With the 26 of May around the corner, and as response to the call from the Council of the EU (EPSCO), the MDCG (Medical Device Coordination Group) has issued a document stating the challenging joint responsibility Member States and the Commission have, together with the concerned stakeholders, to ensure that the new legislation on medical devices is operational from the aforesaid date.
As a matter of fact, the document resembles very much to a “To-do List” rather than to a paper showing any recently achieved progress on what is necessary to secure the proper functioning of the MDR.
Throughout the document, nuances of the EU principle of subsidiarity are revealed as, even though many tasks have to be accomplished by the European Commission to ensure a harmonized approach and smooth application of the MDR, other tasks are best done by the Member States to ensure that provisions are effectively applied and enforced at a national level. In consequence, the document acts as a call for those involved to further step up their effort and work closely together.
Priority and contingency actions are identified on the basis of public health, patient safety and transparency… What is considered to be essential to have an operational system in place by May 2020 and who is responsible for each task?
I. EUDAMED
- Release and make available the actor module allowing the Economic Operators to obtain a Single Registration Number (SRN) once the concerned Competent Authority has verified the registration request and executed the issuing;
- Position paper on the use of SRNs and call for a common approach on the issuance of SRNs across the EU (MDCG);
- Guidance on harmonized administrative practices and technical solutions in the absence of EUDAMED (MDCG);
- Fact sheet listing the information which will be available to the public in accordance with transparency obligations once EUDAMED is fully functional (MDCG);
- Provide regular updates to Member States and stakeholders on the development of EUDAMED towards full functionality (Commission services);
- Establish a sub-group on EUDAMED under the MDCG to facilitate the work on the focus, establishment, management and maintenance of EUDAMED, both at policy and technical level (Commission services).
II. PLACING SAFE DEVICES ON THE MARKET AFTER 26 MAY 2020
- Guidance on the application of the transitional period, notably in relation to the interpretation of conditions concerning “significant changes” in accordance to Article 120 (3) of the MDR (MDCG);
- Guidance on the consultation of relevant authorities for legacy devices with ancillary substances or manufactured using TSE susceptible animal tissues (MDCG);
- Guidance on how affected manufacturers of some class I devices can make efficient use of the transitional provisions in Article 120 (3) and (4) of the MDR (MDCG);
- Request regular reporting from industry and notified bodies, and monitor market developments and activities performed by notified bodies aiming at detecting possible delays that could lead to shortage of devices on the market (Member States and Commission services);
- Examine different means to ensure availability of safe and critical medical devices and provide guidance, as appropriate (Member States and Commission services);
- Provide for mechanisms to communicate between Member States Authorities and the Commission on availability, potential risk of shortages and measures taken to ensure availability of safe and critical medical devices (Member States and Commission services).
III. CLINICAL EVALUATION AND EXPERT PANELS
- Guidance on clinical evidence needed for medical devices previously certified under Directives 93/42/EEC and 90/385/EEC (legacy medical devices) and on equivalence for well-established technologies (MDCG);
- Nominate experts of the Expert Panels and publish a list of experts, as well as provide information on a dedicated webpage on the functioning of the panels (Commission services);
- Establish the Expert Panels for Clinical/Performance Evaluation Consultation Procedures (CECP/PECP) (Commission services).
IV. IMPLEMENTING ACTS
- Already adopted on the designation of the twelve new Expert Panels, UDI infrastructure and the list of codes for types of devices for specifying the scope of notified bodies;
- Under preparation: implementing decision on a standardization request to CEN/CENELEC for MDR/IVDR harmonized standards and the Implementing Regulation on Common Specifications for the reprocessing of single-use medical devices.
Evidently, monitoring the transition progress and market developments is considered to be crucial both ahead of May 2020 and beyond. Therefore, the Commission’s services intend to continuously request regular updates from the industry and notified bodies and to cooperate closely with Member States and stakeholders to early identify potential problems and find adequate solutions. Specifically, on the following matters:
- AVAILABILITY OF MEDICAL DEVICES ON THE MARKET
- CAPACITY OF NOTIFIED BODIES
- NOTIFIED BODY DESIGNATION
- EXTENSION OF THE MDR SCOPE
24/03/2020
Carlos Francisco Marín Barrios
Regulatory Affairs Department
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