Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities have been an important part of conformity to the European Union’s (EU) Medical Device Directive 93/42 EEC (MDD) and Active Implantable Device Directive 90/385/EEC (AIMD) since their inception. However, under the new EU Medical Device Regulation 2017/745 (MDR), there is an increased emphasis on PMS and PMCF data, in addition to new and expanded requirements.
These changes have generated uncertainties for medical device manufacturers regarding the expectations of PMS and PMCF under the existing directive. Although the new MDR builds on the framework of the current MDD and AIMD regulations, the MDR presents several challenges that must be addressed by device organizations.
This White Paper delivers a deeper understanding of how leveraging PMS and PMCF data can support conformity with the new MDR by the mandatory enforcement date of 26 May 2020. In addition, provided are various online tools and forms to assist medical device manufacturers with compliance planning and implementation.
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