By Stewart Eisenhart, Emergo Group
The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs were released by the EU Commission with significant fanfare on 26 September 2012. The weaknesses cited in the Executive Summary/Impact Assessment of the EU regulatory system, were not a shock. The MDEG report (2002) had identified these as areas of concern. In reviewing the changes it became apparent to us there are several themes in the proposed legislation: Oversight of Notified Bodies, Post-market safety, Transparency and traceability, access to external expertise and management of the regulatory system. The impact of the PIP scandal was apparent.
While the European medical device regulatory system remains largely intact, greater detail has been added, and new mechanisms exist to bolster the weaknesses. The legislation is a regulation which applies as drafted to all member states and at the same time. The days of subsidiarity and member state autonomy are over though each member state is required to nominate a member and alternate to the Medical Device Coordination Group (MDCG). Here is a high level overview of the primary changes. Download our white paper if you want an in-depth analysis of the new European medical device changes.
- Greater emphasis is placed on encouraging member state cooperation, interaction among the entities, and the use of the European database and UDI.
- It is apparent that much of the European guidance (MEDDEVs) and GHTF guidance is now codified, making them mandatory.
- Additional member state registration requirements have been removed. This was an issue in Italy, as an example.
- Manufacturers (and Authorized Representatives) must have a Qualified Person.
- The definitions section is significantly expanded. Economic operators are defined, and responsibilities assigned, which means importers and distributors are formally recognized as important elements in the supply chain as well.
- The use of European Norm (EN) harmonized standards to demonstrate compliance is still present despite the controversy over many of the standards.
- Another mechanism, Common Technical Specifications, is also introduced.
- Available routes to conformity assessment are consolidated.
- Notified Body requirements and activities are expanded, including unannounced inspections and sample testing.
- The MDCG will review Notified Body applications, Class III applications for CE marking, and foster coordination of clinical data, vigilance and market surveillance.
The changes are expected to go into effect in three years from date of publication of the Regulations in the OJEU. It has been mentioned that this is expected to be published in 2014, with an effective date at the earliest of 2017. From our perspective, the changes are far reaching but beneficial. You can read much more about the changes by downloading our free PDF entitled “Europe’s Proposed Medical Device Regulation.”
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
