CE marking indicates that products comply with all the relevant directives, regulations and standards required for their sale within the European Economic Area (EEA). While this is a requirement for selling products throughout the European community, it also serves as a stepping stone for marketing in other international markets.
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Published in May 2017, the MDR is formally the definitive regulation governing the marketing of medical devices within the European Economic Area (EEA). The regulation is based on a lifecycle approach and replaces both the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the Medical Devices Directive (MDD) 93/422/EEC. The MDR strengthened regulatory emphasis on Design Control, Process Validation, Clinical data and Clinical evaluations while elaborating guidance pertaining to post-market evaluations and vigilance efforts.
Classification rules, detailed in Annex IX of the European Medical Device Regulation (MDR, EU 2017/745), relate, among others, to the following criteria:
Compliance with EU directives and regulations and the eligibility for CE marking is assessed by a Notified Body
Preparing the CE dossier could be a cumbersome process as it involves many different documents, templates, reports, and charts reflecting at least as many intricate processes and decision maps. GEMARMED’s experts are well versed in the practice of CE dossier compilation and can guide you through the process or assist in preparing all pertinent documentation, ensuring a successful registration of your device in the EEA. GEMARMED maintains long-standing relationships with various Notified Bodies. We are familiar with their specializations and are able to direct our clients to the Notified Body most appropriate for their products.
The transition from the MDD to the MDR poses strenuous demands on manufacturers. In order to be compliant with the MDR requirements, manufacturers will need to assess their Quality Management System and the technical documentation of their products and close any gaps. Conducting this gap analysis can be time consuming and costly. GEMARMED’s experts have years of experience navigating the ever-changing international regulatory medical device environment and can help ease the transition process for your company.
We additionally offer our services as the Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person, a new requirement set by the MDR to ensure regulatory compliance