The most pivotal new organization formed out of the new Medical Device and IVD Regulations has just been set up. During its first meeting on November 28, the EU Medical Devices Coordination Group (MDCG), focused on the most pressing implementation issues under the new Regulations and on organizational issues.
The MDCG will have a range of responsibilities focused on the successful implementation of the new rules and an ongoing role related to high-level decisions on all aspects of the new Regulations. Its responsibilities will include:
- Assessment and designation of notified bodies and other notified body-related activities;
- Scrutiny of high-risk devices;
- Borderline decisions;
- Contribution to the development of Common Specifications and scientific guidelines, including product-specific guidelines, on clinical investigation of certain devices, in particular, implantable devices and class III devices;
- Assisting the member states in their coordination activities in particular, in the fields of classification and the determination of the regulatory status of devices, clinical investigations, vigilance and market surveillance; and
- Provision of scientific, technical and clinical opinions and advice.
Its full list of responsibilities, including a comprehensive listing of duties under the title provision of scientific, technical and clinical opinions and advice, are set out in Chapters VIII of the MDR and IVDR (Articles 105 and 106 of the MDR and Article 99 of the IVDR).
Who Does What On The MDCG?
The group comprises medtech expert representatives from the competent authorities and effectively replaces the Medical Devices Expert Group (MDEG), which had been made up of representatives from the authorities and other stakeholders, including industry and notified bodies.
The exclusion of industry has been a source of contention for manufacturers, but the Regulations make it clear that the MDCG will set up subgroups to gain access to necessary in-depth technical expertise. These subgroups may also comprise industry and other stakeholders (MDR, Article 103,7; IVDR, Recital 83).
The European Commission will chair the MDCG but not take part voting. It will also provide a framework for the competent authorities to exchanges experiences, as well as providing technical, scientific and logistic support to the MDCG and its subgroups.
The Commission will also organize the meetings of the MDCG and its subgroups, participate in those meetings and ensure the appropriate follow-up.
How The MDCG Is Connected
THE MDCG EFFECTIVELY LIES AT THE CENTER OF INITIAL MEDICAL DEVICE IMPLEMENTATION ACTIVITIES AND ONGOING RESPONSIBILITIES, AS OUTLINED IN THIS TABLE
Getting the MDCG Off The Ground
Setting up the MDCG is understood to be the subject of one of the most pressing of the 118 Implementing and delegated acts that are due to be published as a means to fully implement the MDR and IVDR.
The MDR and IVDR make it clear that the MDCG has to establish its rules of procedure, including:
- The adoption of opinions or recommendations or other positions, including in cases of urgency;
- The delegation of tasks to reporting and co-reporting members;
- The implementation of Article 107 regarding conflict of interests; and
- The functioning of sub-groups.
The newly set-up EU Transitional Measures Taskforce will clarify the role of the MDCG in governance, as part of a high-priority work item within the Commission' roadmap for implementing the MDR and IVDR. This work will include publishing guidance outlining MDCG roles and responsibilities.
Some Initial Duties
One of the first matters that will come before the new group for consideration is endorsing the best practice guide recently issued by the European Commission's Notified Bodies Oversight Group. The document addresses the designation and notification of conformity assessment bodies under the MDR and IVDR.
The MDCG will also work with the Commission to draw up the urgent plan for the implementation of the specifications related to the new Eudamed medical device and IVD database.
Medtech Insight understands that a Commission internal validation process will now follow. After that, the MDCG should be included in the Commission's Register of Expert Groups and Other Similar Entities. For each expert group, the register provides information, including on the Commission department which is running the group, as well as on its members and its mission and tasks. The register also identifies relevant documents that are produced and discussed by the groups.