Challenges for Medical Device manufacturers as the European Medical Device Regulations (MDR 2017/745) will enter into force
Substantial changes were included in the new “REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MEDICAL DEVICES, AMENDING DIRECTIVE 2001/83/EC, REGULATION (EC) No 178/2002 AND REGULATION (EC) No 1223/2009 AND REPEALING COUNCIL DIRECTIVES 90/385/EEC AND 93/42/EEC” published in May 2017 (MDR 2017/745)
The Regulations will enter into force in 26 May 2020 bringing key changes related to the aspects of market surveillance, device identification and traceability, Conformity Assessment, Clinical Evaluation, and Safety.
Medical device manufacturers will be challenged to prove the clinical safety or performance for their medical devices placed on market in a more rigorous way. Requirements for clinical data and clinical investigation will be replacing the equivalence.
Mandatory Unique Device Identification (UDI) will be introduced with the intention to facilitate the traceability of devices.
Also, manufacturers will be required to report a serious incident (or Field Safety Corrective Action (FSCA)) to the relevant using EUDAMED within 15 days, in case of death or unanticipated serious health deterioration the maximum is 10 days. In case of a serious public health threat this timeframe is limited to two days.