What is CE certification and why is it important?
A medical device placed on the EU market must have a CE (“Conformité Européenne”) certification and comply with the EU Medical Devices Regulation (MDR; Regulation (EU) 2017/745) [1] or the EU In Vitro Diagnostic Medical Devices Regulation (IVDR; Regulation (EU) 2017/746) [2]. For devices imported into the European Economic Area (EEA), the importer assumes responsibility for obtaining CE certification. Successful certification confirms that the medical device meets specific quality, safety and health protection standards, allows marketing throughout the EEA, and reassures patients and health professionals that the device has undergone appropriate risk assessment.
Overview of the CE certification process
Certification of a medical device can be lengthy and you will need to:
- Designate a person responsible for regulatory compliance
- Classify your medical device (Class I, IIa, IIb or III) or in vitro diagnostic medical device (Class A, B, C or D)
- Prepare a technical file and pass a conformity assessment for compliance with the EU MDR/IVDR
- Draw up a declaration of conformity – you state that you will assume all responsibility for compliance with the MDR/IVDR
- Assign a unique device identifier and submit key device information to the European Database on Medical Devices (EUDAMED)
- Apply CE marking to your medical device
- Comply with post-certification/post-market requirements
Notified Body role
With the exception of most low-risk devices (Class I and Class A), medical devices will need a conformity assessment to be carried out by an organisation designated by an EU country as a Notified Body [3]. The Notified Body is responsible for reviewing your device's quality and risk management procedures, technical information and clinical evaluation documentation to ensure compliance with the MDR or IVDR [4]. Once the Notified Body has completed their audit, they should provide certification confirming MDR/IVDR compliance.
Technical documentation
Technical documentation is required for all classes of medical devices. The exact requirements of the technical report are complex (see Annexes II and II of the MDR and IVDR) but it should include the following at a minimum:
- Device description and specification (including variants and accessories)
- Package/device labels, including instructions for use (in all official EU member state languages)
- Design and manufacturing information
- Information demonstrating conformity with the general safety and performance requirements of the MDR and IVDR (Annex I)
- A benefit-risk analysis and details of risk management
- Results of product verification and validation, including pre-clinical and clinical data
- Post-market surveillance findings
Clinical evaluation
You should also undertake a clinical evaluation to monitor the general safety and performance of your medical device (see MDR Annex XIV). It is possible for this evaluation to be based on clinical data relating to a device for which equivalence can be demonstrated.
In practice, the clinical evaluation will typically involve a critical assessment of the relevant scientific literature, alongside the results of all available clinical investigations.
Post-certification/post-market requirements
You must maintain updated technical documentation throughout the device lifetime and perform appropriate post-market surveillance and vigilance assessments, including risk management and post-market clinical follow-up (PMCF). For certain classes of device, you must submit periodic safety update reports (PSURs), as well as report serious incidents to the relevant competent authorities within specific timeframes after becoming aware of an incident. The overall objective is to confirm and continuously assess the safety and performance of the device throughout its expected lifetime, and to identify any need to apply corrective or preventive actions.
How can bibra help with CE certification of your medical device?
The pathway to CE certification is complex. This blog gives only a very brief overview of the process, and reading the MDR and/or IVDR to get a more complete picture of requirements is strongly recommended. In conjunction with either company in-house scientists or expert partner consultancies, bibra toxicologists can provide support on the safety/health risk aspects of the technical documentation, as well as ISO 10993 or 18562 biocompatibility evaluations and safety update reports. Please contact us if a more detailed description of the CE certification process would be useful.
References
[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
[2] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. https://eur-lex.europa.eu/eli/reg/2017/746/oj
[3] European Commission. Notified bodies. Accessed July 2023. https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en
[4] BSI. British Standards Institution. What is the role of a Notified Body and UK Approved Body? Accessed July 2023. https://www.bsigroup.com/en-GB...
Other useful references
[5] MHRA. Medicines and Healthcare products Regulatory Agency. An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR). Accessed July 2023. https://assets.publishing.serv...
[6] EMA. European Medicines Agency. Medical devices. Accessed July 2023. https://www.ema.europa.eu/en/h...).
[7] Cite Medical. An Overview of the CE Marking Process in the European Union. Accessed July 2023. https://www.citemedical.com/ce...
[8] ISO 13485:2016. Medical devices - Quality management systems - Requirements for regulatory purposes. https://www.iso.org/standard/59752.html
[9] ISO 14971:2019. Medical devices — Application of risk management to medical devices. https://www.iso.org/standard/72704.html