The Regulatory Affairs Professional Society (RAPS) is reporting that the Spanish Notified Body (NB) is winding down it certification of medical devices for compliance with the European Union’s (EU’s) Medical Device Directive (92/42/EEC, frequently referred to as the MDD), amplifying concerns about the certification resources available to demonstrate compliance with the EU’s Medical Device Regulation (2017/745, the MDR).
The RAPS article, posted to its website in late May, confirmed that the Spanish Agency of Medicines and Medical Products (AEMPS), acting as NB 0318, has ceased accepting medical device applications from new clients for CE marking under the MDD as of June 1st, and will cease accepting new certificate applications from existing clients as of the end of July. AEMPS said that its decision reflects the nearly one-year timeframe required for completing an evaluation under the MDD and aligns with the final date for transitioning to the requirements of the MDR, which is the end of May 2020.
No decision has yet been reached on whether AEMPS will be designated as an NB under the more rigorous NB requirements of the MDR. However, RAPS reports that only two testing organizations in the EU have been designated as NBs under the MDR, raising further concern within the medical device community about the resources available for MDR certification.