The new EU Medical Device Regulation (EU Regulation 2017/745 - EU Medical Device Regulation) came into force on 25 May 2017. The transitional period for implementation by manufacturers of already approved medical devices provided for in the regulation ends on 26 May 2020. Due to the current corona situation, there are now discussions about extending this transitional period by another year.
But what exactly does this mean?
Manufacturers would have another year to meet the requirements of the MDR, combined with more stringent requirements compared to the Medical Device Directive 93/42/EEC. Many companies are already well prepared. For them, the possible postponement of the deadline means an opportunity to make their new established quality management system even more stable.
The time gained can be used, for example, to safely implement the increased requirements of, for example, post market surveillance. The training of employees to meet the extended knowledge requirements could also now be carried out more sustainably. What, for example, does the new role of the Person Responsible for Regulatory Compliance (PRRC) involve?
gempex offers expert support here - also remotely.