BVMed and VDGH, the German MedTech Association, publish a whitepaper to initiate a dialogue to improve regulation of medical devices in Europe

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 ๐ญ๐ก๐ž ๐œ๐ฎ๐ซ๐ซ๐ž๐ง๐ญ ๐ฌ๐ญ๐š๐ญ๐ฎ๐ฌ
๐Ÿ‘‰Complex and non-transparent regulations, lack of regulations for #orphandevices
๐Ÿ‘‰Niche Products and Fast Track
๐Ÿ‘‰Challenging new product development and respective launch
๐Ÿ‘‰Declining attractiveness of the CE mark
๐Ÿ‘‰Foreseeable shortage of medical devices
๐Ÿ‘‰Reduced pace of innovation

and proposes changes/improvements in five basic pillars, namely,

๐€๐ƒ๐ƒ๐ˆ๐“๐ˆ๐Ž๐๐’ ๐“๐Ž ๐“๐‡๐„ ๐‚๐”๐‘๐‘๐„๐๐“ ๐‘๐„๐†๐”๐‹๐€๐“๐Ž๐‘๐˜ ๐…๐‘๐€๐Œ๐„๐–๐Ž๐‘๐Š
๐Ÿ‘‰ Fast-track procedures (accelerated procedures) in alignment with other international regulatory frameworks for
๐Ÿ‘‰ Innovative products
๐Ÿ‘‰Orphan Devices and Diagnostics for rare diseases
๐Ÿ‘‰Niche products with a proven track record

๐ˆ๐๐‚๐‘๐„๐€๐’๐ˆ๐๐† ๐“๐‡๐„ ๐„๐…๐…๐ˆ๐‚๐ˆ๐„๐๐‚๐˜ ๐Ž๐… ๐“๐‡๐„ ๐’๐˜๐’๐“๐„๐Œ
๐Ÿ‘‰Consistent implementation of the principles of good administrative practice,
๐Ÿ‘‰ Predictable deadlines and calculable costs of the regulatory procedures
๐Ÿ‘‰ Equal access for everyone to the regulatory system
๐Ÿ‘‰ Increased transparency of the #certification processes also through digitization
๐Ÿ‘‰ Effective legal remedies against market access decisions
๐Ÿ‘‰ Better coordination of central and national legislation

๐‘๐„๐…๐Ž๐‘๐Œ ๐Ž๐… ๐“๐‡๐„ ๐’๐“๐€๐๐ƒ๐€๐‘๐ƒ ๐…๐ˆ๐•๐„-๐˜๐„๐€๐‘ ๐‘๐„-๐‚๐„๐‘๐“๐ˆ๐…๐ˆ๐‚๐€๐“๐ˆ๐Ž๐ ๐‚๐˜๐‚๐‹๐„
๐Ÿ‘‰ Abolish the limited validity period of the certificates of five years
๐Ÿ‘‰ More efficient and risk-based certification cycle based on post-market data
๐Ÿ‘‰ IVDR: Self-certification of products with a low-risk class (class B) to relieve the system and eliminate bureaucratic reports without patient benefit

๐ˆ๐Œ๐๐‘๐Ž๐•๐„๐Œ๐„๐๐“ ๐Ž๐… ๐ˆ๐๐“๐„๐‘๐๐€๐“๐ˆ๐Ž๐๐€๐‹ ๐‚๐Ž๐Ž๐๐„๐‘๐€๐“๐ˆ๐Ž๐๐’
๐Ÿ‘‰Restore the international reputation of the CE marking
๐Ÿ‘‰ Increased involvement of the EU in the MDSAP program for quality management systems
๐Ÿ‘‰ Mutual Recognition Agreements (MRAs) of the EU with Switzerland and the UK

๐‚๐„๐๐“๐‘๐€๐‹๐ˆ๐™๐€๐“๐ˆ๐Ž๐ ๐Ž๐… ๐‘๐„๐’๐๐Ž๐๐’๐ˆ๐๐ˆ๐‹๐ˆ๐“๐˜
๐Ÿ‘‰ Introduce a central accountable management structure
๐Ÿ‘‰ Harmonize and centralize notification and monitoring of the notified bodies across
๐Ÿ‘‰ Europe to set up anย  SME office at EU level

The initiative is national and based on Germanyโ€™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.

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