The German medtech industry association, BVMed – Bundesverband Medizintechnologie, and its IVD counterpart, VDGH – Verband der Diagnostica-Industrie e.V., have taken up an initiative to propose a set of actions that do not only intend to facilitate the implementation of MDR & VDR but also to start a discussion with all involved stakeholders about the overall improvement of regulation of medical devices in Europe.
The whitepaper describes 𝐭𝐡𝐞 𝐜𝐮𝐫𝐫𝐞𝐧𝐭 𝐬𝐭𝐚𝐭𝐮𝐬
👉Complex and non-transparent regulations, lack of regulations for #orphandevices
👉Niche Products and Fast Track
👉Challenging new product development and respective launch
👉Declining attractiveness of the CE mark
👉Foreseeable shortage of medical devices
👉Reduced pace of innovation
and proposes changes/improvements in five basic pillars, namely,
𝐀𝐃𝐃𝐈𝐓𝐈𝐎𝐍𝐒 𝐓𝐎 𝐓𝐇𝐄 𝐂𝐔𝐑𝐑𝐄𝐍𝐓 𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐅𝐑𝐀𝐌𝐄𝐖𝐎𝐑𝐊
👉 Fast-track procedures (accelerated procedures) in alignment with other international regulatory frameworks for
👉 Innovative products
👉Orphan Devices and Diagnostics for rare diseases
👉Niche products with a proven track record
𝐈𝐍𝐂𝐑𝐄𝐀𝐒𝐈𝐍𝐆 𝐓𝐇𝐄 𝐄𝐅𝐅𝐈𝐂𝐈𝐄𝐍𝐂𝐘 𝐎𝐅 𝐓𝐇𝐄 𝐒𝐘𝐒𝐓𝐄𝐌
👉Consistent implementation of the principles of good administrative practice,
👉 Predictable deadlines and calculable costs of the regulatory procedures
👉 Equal access for everyone to the regulatory system
👉 Increased transparency of the #certification processes also through digitization
👉 Effective legal remedies against market access decisions
👉 Better coordination of central and national legislation
𝐑𝐄𝐅𝐎𝐑𝐌 𝐎𝐅 𝐓𝐇𝐄 𝐒𝐓𝐀𝐍𝐃𝐀𝐑𝐃 𝐅𝐈𝐕𝐄-𝐘𝐄𝐀𝐑 𝐑𝐄-𝐂𝐄𝐑𝐓𝐈𝐅𝐈𝐂𝐀𝐓𝐈𝐎𝐍 𝐂𝐘𝐂𝐋𝐄
👉 Abolish the limited validity period of the certificates of five years
👉 More efficient and risk-based certification cycle based on post-market data
👉 IVDR: Self-certification of products with a low-risk class (class B) to relieve the system and eliminate bureaucratic reports without patient benefit
𝐈𝐌𝐏𝐑𝐎𝐕𝐄𝐌𝐄𝐍𝐓 𝐎𝐅 𝐈𝐍𝐓𝐄𝐑𝐍𝐀𝐓𝐈𝐎𝐍𝐀𝐋 𝐂𝐎𝐎𝐏𝐄𝐑𝐀𝐓𝐈𝐎𝐍𝐒
👉Restore the international reputation of the CE marking
👉 Increased involvement of the EU in the MDSAP program for quality management systems
👉 Mutual Recognition Agreements (MRAs) of the EU with Switzerland and the UK
𝐂𝐄𝐍𝐓𝐑𝐀𝐋𝐈𝐙𝐀𝐓𝐈𝐎𝐍 𝐎𝐅 𝐑𝐄𝐒𝐏𝐎𝐍𝐒𝐈𝐁𝐈𝐋𝐈𝐓𝐘
👉 Introduce a central accountable management structure
👉 Harmonize and centralize notification and monitoring of the notified bodies across
👉 Europe to set up an SME office at EU level
The initiative is national and based on Germany’s central role in the medtech industry due to the increased No of manufacturers based in the country. BVMed has already approached the European Commission, Member States (France is already on board with these proposals), and notified bodies. BVMed stakeholders are confident that all parties will see the added value of this proposal and will work towards its implementation.
Read more bvmed-und-vdgh-whitepaper-zur-zukuenftigen-entwicklung-der-mdr-und-ivdr
