Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure. For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified Bodies,” are involved.
What are Notified Bodies?
Notified Bodies are entities that have been accredited by the competent authority of a European Member State to assess the conformity of the products with the relevant EU legislation. Their legal status varies from public bodies to associations and commercial undertakings. Today, 29 EU legislative regimes are implemented in practice by the involvement of Notified Bodies. These regimes include the rules on personal protective equipment, marine equipment, toys, and machinery. For medical devices, 78 Notified Bodies have been designated for the assessment under one of the three Directives currently regulating medical devices in the EU,i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDs).
Calls for Reform
Following the numerous reports that the German Notified Body, TÜV Rheinland, did not detect alleged fraud committed by French breast implant manufacturer Poly Implant Prothèse, there has been renewed scrutiny of the role of Notified Bodies. In addition, various stakeholders have reported differences regarding the designation of Notified Bodies and the quality of the conformity assessment performed by them (in particular in relation to the assessment of clinical evaluation of the product). These stakeholders have alleged that the varying quality of Notified Bodies could lead to an uneven level of patient protection and a possible distortion of the competition between manufacturers of similar products.
Notified Bodies With More Power But Under Stricter Control
As a result, the Commission decided to address this issue in its two proposals for the revision of the EU regulatory framework for medical devices by tackling both the duties of Notified Bodies and the control exercised over them. Under the proposals, the rights and duties of Notified Bodies vis-à-vis manufacturers would be reinforced. This will include, for example, carrying out unannounced factory inspections and conducting physical or laboratory tests on devices.
At the same time, the proposed regime includes stricter and more detailed criteria for the designation and monitoring of Notified Bodies by Member States’ competent authorities. These relate, among other aspects, to their financial and human resources capacities. In particular, the proposal requires rotation of the personnel involved in the assessment of medical devices at appropriate intervals. The purpose of this rotation is to “strike a reasonable balance between the knowledge and experience required to carry out thorough assessments and the need to ensure continuous objectivity and neutrality in relation to the manufacturer subject to those assessments.” Moreover, any new designation and the regular monitoring of Notified Bodies are made subject to “joint assessments” with experts from other Member States and the European Commission. Finally, for new applications for conformity assessment of high-risk devices, Notified Bodies would be under “scrutiny” of an expert committee, the Medical Devices Coordination Group, as described inour post on the scrutiny procedure.
Like the rest of the proposals, these new rules would become law if adopted by the European Parliament and the Council. Our earlier post on the legislative process describes this procedure in more detail.