RegPro Medical

CE Marking your medical device unlocks access for your device sales in the 30 countries of the European Union (EU) and European Economic Area (EEA). The EU medical device market is the second largest in the world after the USA, comprising an estimated 26% of the world market at USD $173 Billion* and growing on average by 5.4% per year over the past 10 years*.  CE Marking is a multi-faceted process that requires careful planning and close management.  Some of the key steps are:

• Classify your device: based on the intended use and risk profile, into Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk) according to the EU classification rules.

• Appoint an Authorized Representative: An Authorized Representative with a physical location in EU is required.  The Authorized Representative will be your point of contact with the regulatory authorities and will have specific responsibilities defined in the regulation.

• Contract with a Notified Body: Unless your device is Class I, a Notified Body must evaluate your device and quality management system and issue a CE certificate. The Notified Body will review your technical documentation or specific aspects of the documentation such as sterility or reprocessing requirements.  This review can take anywhere from 6 months to 2 years.

• Conduct MDR Clinical Evaluation: Every device to be CE-marked requires a clinical evaluation.  Whether your device is already marketed elsewhere or initially launching, a clinical evaluation plan that meets EU-specific requirements is required.  The level of effort and investment can range from re-assessment of existing clinical data to conducting complex clinical studies.

• Upgrade Quality Management System (QMS): The QMS requirements for CE Marking go beyond the basic ISO 13485 requirements.  This includes detailed requirements for clinical evaluation, complaint handling, adverse event (vigilance) reporting, and post-market surveillance.

• Compile Technical Documentation: A more thorough technical documentation file is required.  The technical file includes documented evidence that the device meets all of the general safety and performance requirements of the EU MDR regulation. 

• Update Labeling: The EU has unique requirements for labels and instructions that will need to be added in your labeling.  Labels and other information provided with the device have to be in the appropriate language for the countries in which you sell your device.

• Assign Unique Device Identifier (UDI): An identification number meeting specific technical requirements and issued by an approved agency must be applied on the device labels and registered in the EUDAMED database.

• Register in EUDAMED: Each medical device manufacturer must register in the EUDAMED database and obtain a single registration number “SRN”.  Each medical device must be registered.