- The European Commission’s Medical Device Coordination Group (MDCG) published new guidance Wednesday on incoming EU regulations.
- In two separate texts, MDCG sets out its position on codes for the designation of notified bodies and the sampling of moderate-risk medical devices and in vitro diagnostics.
- The latest advice comes fives months before the EU Medical Device Regulation is set to come into force.
The EU Medical Device Regulation (MDR) sets requirements for sampling Class IIa and Class IIb devices. The in vitro diagnostics equivalent, IVDR, sets comparable requirements for Class B and Class C products. In both cases, notified bodies will use sampling to assess technical documentation before issuing a quality management system certificate.
The MDCG guideline sets sampling criteria based on the regulations. The criteria differ somewhat between Class IIa and Class IIb products, as well as between their IVD equivalents, but the objective of reviewing technical documentation for one or more “representative” products is universal.
Elsewhere in the guideline, MDCG covers the sampling of technical documentation notified bodies should perform after issuing QMS certification. MDCG expects these ongoing assessments to follow a sampling plan, the development of which should be informed by the “inherent risk” of devices. The notified body must document its rationale for sampling decisions and the chosen criteria.
MDCG published the sampling guideline on the same day as it released an explanatory note on MDR codes. The note discusses the incoming regulations on codes to describe a notified body’s scope of designation. That scope dictates whether a notified body is able to assess a particular application.
The explanatory note describes three types of coding that cover a device’s intended purpose, specific characteristics and technologies or processes. Notified bodies will use the codes to inform decisions about the allocation of conformity assessment personnel to the review of technical documentation and performance of site audits.
Publication of the MDCG documents follows changes to the planned implementation of MDR. In recent weeks, the European Commission delayed the launch of the Eudamed database by two years and another branch of the EU machinery voted to ease the pressure on manufacturers of certain Class I devices by selectively pushing back the MDR enforcement deadline.
The new round of activity follows warnings that the industry is ill prepared for May 2020 implementation of MDR, in part because of concerns that too few notified bodies are in place to handle the work.