Will Your Notified Body Be Ready for Your EU MDR Certification?
With the May 26, 2020 enforcement deadline for compliance with the Medical Device Regulation (EU MDR) approaching and the uncertainty of Brexit, medical device manufacturers and regulatory professionals are facing difficult moments. Notified Bodies around the world, as well as medical device companies are expending significant time and resources adapting their products and services to comply with the new requirements of the EU MDR and planning for an efficient and smooth transition.
An important British Notified Body has just announced their decision not to apply for EU MDR accreditation. They have suggested that their clients turn to an alternative Notified Body.
Certainly, this is a difficult period for the entire medical device industry, which must address many challenges and crucial decisions. In order to be prepared, it is crucial to focus on the technical and regulatory aspects related to the transition and engage with competent professionals.
ECM works hard to maintain the highest levels of services. We are still accepting new requests for CE certification under the Medical Devices Directive (MDD) and, at the same time, we are preparing for the new EU MDR accreditation, as we are scheduled to receive the joint assessment by the EU Commission and the Italian competent authorities.