The Medical Device Directive is set to receive a major update:
The new MDR will substitute the directives 93/42/EWG for Medical Devices, as well as 90/385/EWG for active implantable medical devices. In Vitro Diagnostics will receice their own directive.
Changes due to the new MDR:
The MDR will combine the formerly standalone directives mentiones above starting at the end of the year 2016 or early 2017. The combination will be accompanied by some essential changes that impact the requirements for proper labeling – among other things. It is thus quite important to prepare the transition before the new regulation becomes active to minimize delays or other problems resulting from the changes and additions.
But what are the most important changes?
- More detailed requirements for the technical documentation and its update frequency.
- New requirements for labelling of Medical Devices.
- Manufacturers must employ a qualified person with expert knowledge of Medical Devices.
- EUDAMED (European Databank for Medical Devices) will be enhanced and partially made available to manufacturers, notified bodies and the public.
- Clinical trials and evaluation will have stricter and more detailed regulations.
- Introduction of “special notified bodies” for high risk medical devices.
- Changes in the classification of some Medical Devices.
This means that manufacturers have to invest more time and ressources into the documentation of Medical Devices in order to comply with the new regulations.
Manufacturers are granted a three year transitional period to adapt the new regulations.