Pharma Intelligence is part of the Business Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
The EU body that will drive implementation of the new Medical Device and IVD Regulations and maintain central decision-making powers has been set up. It's early days, but the Medical Device Coordination Group is off and running.
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:
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).
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
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 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.
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.
Biomedtracker: follow the drug development process
03 Apr 2017
Learn why pharmaceutical, biotech, and investment companies rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication.
Scrip: industry news and insights
Hong Kong is catching global attention as it plans to drastically change listing rules for biotech firms, potentially opening the way to both Chinese companies seeking public funding and international firms eyeing entry to China. A Shanghai biosimilars developer, among others, is now eyeing an offering.
Topics Policy and regulation
Scrip: industry news and insights
Mylan’s Symfi and Merck’s Zepatier gain preferred status on PBM's national preferred formulary for 2019. But more drugs are excluded from coverage – 242, up from 196 in 2018. <br />
Request a Trial
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
How can we help you?
Our team is always happy to hear from you. Please call us at:
Pharma Report Store
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now:
Get a window into what the leading players across the biopharma, medtech, and diagnostics industries are thinking, as well as important insight into what your competitors are doing. Build your strategy with In Vivo.
In the continually evolving medtech competitive landscape, it is vital to stay up-to-date with key events. With Meddevicetracker, you’ll be able to anticipate upcoming filings, research clinical trial dates and data, and access market size information and expert forecasts, all in one place.
Looking for more products Product Finder
