This is a Heads Up during the ongoing implementation of the new EU regulations for medical devices.
After publication of the Medical Devices Regulation (MDR) in 2017, a transitional period of three years began. It runs to 26 May 2020, and during that period the new regulation will apply in parallel with the former regulations, in order to give the players in the field time to adjust to the new requirements.
The new regulation involves a number of changes. MDR clarifies the obligations, not just for manufacturers, but also for importers and distributors. The requirements for monitoring by notified bodies, conformity assessment procedures, clinical evaluations and trials, safety monitoring and market surveillance have also been made more stringent. In addition, a number of new rules have been introduced that aim to increase transparency and traceability.
Importantly, implementation of a new regulation also means that all of Europe’s notified bodies must be notified again, in accordance with the new rules.
We would like to point out to potential clients that TKT can be an ideal partner in this changing regulatory landscape. In those instances that the new rules necessitate complementary documentation on the safety of a device, TKT will assess and help to resolve any questions involving biocompatibility, including the preparation of biological Evaluation Plans and Biological Evaluation Reports, in accordance with ISO 10993:2009 and ISO 10993:2018. With our extensive experience and expertise, TKT assures each client the required quality, and at the same time, the most cost-effective solution.