PMS planning and Challenges under EUMDR

Davidbhagya20 Nov, 2020Health

While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device Directive (MDD), it was not defined clearly in the MDD. Lack of clarity is completely removed with the publication of the new EU MDR. Not only is PMS defined in Article 2 (60), it is listed as one of the general obligations of all manufacturers (new Article 10). It is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance (new Article 15).