The EU Medical Devices Regulation (MDR) has been published in the Official Journal of the EU. It is now time for companies to start preparing for the application date of the Regulation in May 2020.
In order to guarantee the safety of the patients, the already existing comprehensive official regulations are supplemented by the publication of the new document. While some parts of the existing regulations are aggravated, other regulations were totally replaced. The overall transition period is only three years but under exceptional circumstances it can be extended to five years.
One of the key challenges for medical device manufacturers is the requirement on clinical evaluation with special emphasis on clinical data.
The new regulation involves the intensification of the recommendations for clinical evaluations and studies – clinical data have to be collected, documented and evaluated also after the market launch of the products. Clinical data and the clinical evaluation report require regular updates and the manufactures have to plan and maintain post-market clinical follow-up measures and have to prepare periodic safety update reports (PSUR) for devices class IIa, IIb and III.
Dr. Knoell Consult GmbH experts are happy to help you in order to comply with current and MDR requirements. This may include:
1. Compliance level assessment (data gap analysis) and development of justified waiving strategies
2. Development of
3. Management of the integrity of clinical data and writing of reports and updates
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