European CE Mark Medical Device (EU MDR) Consultant
The CE mark for medical devices confirms compliance with essential regulations for entry into European countries.
Operon Strategist, a leading EU MDR consultant, boasts a substantial presence throughout the EU, extending our support to countless medical device manufacturers to ensure CE compliance for Europe.
What Is CE Marking for Medical Devices?
Selling medical devices in the European Union (EU) requires obtaining CE marking for your medical devices. CE stands for Conformité Européenne. CE marking indicates that your medical device complies with applicable EU regulations and enables the commercialization of your products across all EU member states.
How to Obtain European CE Marking for Your Medical Devices
- Determine if your product aligns with the definition of a medical device as outlined in the EU MDR.
- Determine the medical device classification in Europe for your medical devices.
- Implement a Quality Management System (QMS) if it applies to your device. Many companies utilize ISO 13485 to fulfill these requirements.
- Prepare a CE Marking Technical File or a Design Dossier.
- Compile a Clinical Evaluation Report (CER) following the guidelines of MEDDEV 2.7/1 rev4 and the MDR.
- Select and designate a European Authorized Representative (EC REP) to act on your behalf within the EU if you lack a physical presence in Europe.
- Subject your QMS and Technical File/Design Dossier to an audit by a Notified Body, unless your device falls under Class I, is non-sterile, and lacks a measuring function.
- Obtain CE certificate for medical devices and ISO 13485 certificates from your designated Notified Body.
- Prepare a EU Declaration of Conformity (DoC) confirming that your device complies with the regulations outlined in the MDR.
ISO 13485:2016
FDA 21 CFR Part 820
Countries That Accept the CE Marking for Medical Devices
The Following Countries Currently Require CE Mark for Medical Devices: Austria (since 1995), Belgium, Bulgaria (since 2007), Czech Republic (since 2004), Cyprus(since 2004), Denmark, Estonia (since 2004), Finland (since 1995), France, Germany, Greece, Hungary (since 2004), Ireland, Italy, Latvia (since 2004), Lithuania (since 2004), Luxembourg, Malta (since 2004), The Netherlands, Poland (since 2004), Portugal, Romania (since 2007), Slovakia (since 2004), Slovenia (since 2004), Spain, Sweden (since 1995), Croatia (since July 1, 2013)
Special Cases:
Switzerland: Despite not being an EU member or EEA signatory, Switzerland has incorporated the Medical Devices Directives into its national legislation, necessitating CE marking for specific medical devices.
Turkey: Although not part of the EU or EEA, Turkey has adopted many of the European CE marking directives. Consequently, CE marking is mandatory for numerous medical devices in Turkey.