The introduction of the EU’s new Medical Device Regulation began a three-year transition period that expires on May 26, 2020. Manufacturers need to be sure they understand the requirements of the new regulation to ensure continued compliance.
The European Union’s new Medical Device Regulation (MDR) 2017/745 came into force on May 26th, 2017, superseding Medical Device Directive (MDD) 93/42/EC. This began a three-year transition period, meaning all new devices, their manufacturers and other stakeholders in the field must meet the requirements of the MDR by May 26th, 2020.
During the transition period Notified Bodies (NB) may grant device certification according to the MDD. The certificates are valid for a maximum period of five years, until May 27th, 2024, unless the certified product undergoes significant changes. This does not include certificates issued according to Annex IV, which must expire by May 27th, 2022.
Current NB designations will remain valid until the Directive expires. Following this, they must continue the surveillance of the certificates they have granted until the end of their validity. Applications for NB designation according to MDR are currently being processed, with the procedure expected to take up to a year. SGS Fimko aims to be among the first MDR-accredited NBs.
MDR introduces a number of changes, including:
For manufacturers, harmonised standards may be the easiest way to demonstrate compliance with the requirements of the law. Different editions of the standards are associated with their DOCOPOCOSS (Date of Cessation of Presumption of Conformity of Superseded Standard) – an abbreviation describing the date when an older edition of a standard can no longer be used to demonstrate compliance. Currently there are no harmonised standards for MDR, but state-of-the-art standards can be applied with caution.
Stakeholders should be aware that, in relation to medical devices, the DOCOPOCOSS dates for two standards have either passed or are approaching cessation:
Moving to an updated standard requires collaboration between the testing laboratory and the client. Each device must have its future usage environment and, among other requirements, essential performance, defined to ensure it is maintained during testing.
Stakeholders must also consider which functions will be monitored during testing and what is the definition of a situation where performance no longer meets requirements.
Manufacturers are advised to start considering and documenting these matters immediately.