EUROPEAN UNION (EU)
Medical Device Regulation (EU) 745/2017
The European Union Medical Device Regulation (EU MDR) is a crucial regulatory framework that governs the marketing and sale of medical devices within the European Union. It aims to ensure the safety, quality, and effectiveness of medical devices while enhancing patient protection and streamlining market access. Under the EU MDR, medical device manufacturers must comply with rigorous requirements to obtain CE marking, which certifies their products' conformity to EU standards.
Conformité Européenne (CE) certification is a regulatory standard that verifies certain products are safe for sale and use in the European Economic Area (EEA).
Selling Medical Devices to European Markets
In order to access the European market, manufacturers shall complete appropriate actions allowing them to sell their medical devices. These actions include obtaining one or more CE marking certificates and quality systems [ISO 9001/ISO 13485] which attest devices conformity to European regulatory standards. A notified body is an organization designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market.
EU Good Manufacturing Practice (GMP) Annex 11: Computerized Systems
EU GMP Annex 11 guideline that outlines the requirements for computerized systems used to manufacture human and veterinary medicinal products. EU Annex 11 requires all computerized systems to be validated and IT infrastructure to be qualified.