Proposals by the Notified Bodies to amend the Medical Devices Regulation

The TEAM Notified Bodies has published proposals for revising the regulatory framework for medical devices and in vitro diagnostics (IVDs). What do the Notified Bodies have in mind?

Who is the TEAM Notified Body?

The TEAM Notified Body (TEAM-NB) has been existing since 2001 and currently has 45 members from 19 countries. The aim of the group is to create harmonisation among Notified Bodies.

The position paper

In a position paper ("Revising the Medical Device Regulatory Framework: Team-NB's Concerns and Proposed Solutions"), TEAM-NB sets out, over 3 pages, problems and possible solutions relating to the changes to the medical device and IVD rules proposed by the European Commission. From the Notified Bodies' perspective, the most urgent concerns are:

1.) Patient safety
2.) Transparency
3.) Clarification of definitions
4.) Questions on capacity and fees

On 1): The Commission's proposals envisage "scaling back" quality management system audits, sampling within technical documentation reviews, unannounced audits, expiry dates on certificates and other elements. For the TEAM-NB a risk assessment is lacking with regard to patient safety, what happens if all of these proposals are introduced together. This also hinders comparison with possible alternatives, according to TEAM-NB. TEAM-NB has already published proposals for risk-adapted surveillance.

On 2): The Notified Bodies' request for access to the EUDAMED database has so far not been addressed in the Commission's proposals. TEAM-NB, however, sees transparency as an important aid to medical device safety. In TEAM-NB's view, risk-based surveillance requires this transparency. TEAM-NB also sees difficulties in carrying out risk-based surveillance without access to the EUDAMED database. It emphasises, however, that it maintains the same level of confidentiality as the Member States themselves.

On 3): The proposals for additional conformity assessment procedures for medical devices for rare diseases ("orphan") and for well-established technology (WET) "suffer" from vague definitions. According to TEAM-NB, this could lead to inconsistent interpretations. To remedy this, TEAM-NB proposes introducing standards or specifications.

On 4): Mandatory discounts for small and medium-sized enterprises (SMEs), combined with payment delays for these companies, could lead to fewer customers for these companies. This would in fact be the opposite of what the discounts were intended to achieve. Any intervention in the cost structure has a direct impact on the Notified Bodies. Instead of cutting costs, TEAM-NB recommends supporting SMEs on the basis of existing MDCG guidance for medical devices for rare diseases and "breakthrough" approvals.

Conclusion: On just 2.5 pages, the document sets out the Notified Bodies' proposals for planned changes to the medical device and IVD regulations.

Please see the TEAM NB website for the three-page proposal paper.