Saray Ugidos Seman, Head of Clinical, Regulatory, and Quality Affairs at Aura Health, highlights the critical role of regulatory expertise in the early stages of medical device development. She underscores that startups, in particular, must prioritize regulatory knowledge to avoid costly setbacks and ensure a smoother path to market entry. Many emerging companies underestimate the complexity of compliance, leading to delays, redesigns, and unforeseen financial burdens. Understanding CE certification early not only accelerates commercialization but also strengthens investor confidence and fosters innovation within regulatory boundaries.
A real-world example of this is the German startup Implandata Ophthalmic Products, which specializes in smart implantable sensors for glaucoma monitoring. By integrating regulatory expertise from the outset, they successfully navigated the MDR requirements, conducted necessary clinical evaluations, and achieved CE certification on time. This proactive approach enabled them to bring their innovative technology to market faster and secure funding from investors who recognized their commitment to compliance and patient safety.
CE certification confirms that a medical device meets the European Union’s Medical Device Regulation (MDR) 2017/745 or In Vitro Diagnostic Regulation (IVDR) 2017/746, ensuring it adheres to essential safety and performance standards. This guide explores the scientific and regulatory processes essential for obtaining CE certification, providing startups with key insights to navigate this intricate landscape effectively.
For manufacturers aiming to introduce medical devices into the European market, achieving CE certification is a crucial regulatory step that demonstrates compliance with strict safety, performance, and quality requirements. This certification serves as a declaration that a device meets the stringent requirements set forth by the European Union (EU) under the Medical Device Regulation (MDR) 2017/745 or In Vitro Diagnostic Regulation (IVDR) 2017/746. Adhering to these regulations ensures that medical devices meet stringent safety, performance, and quality standards, reinforcing confidence among healthcare professionals and end-users. This guide provides a structured overview of the scientific and regulatory framework necessary to achieve CE certification, outlining key steps and considerations for manufacturers navigating this complex process.
Understanding CE certification
The CE mark (“Conformité Européenne”) is a symbol that indicates a product’s conformity with EU regulations. For medical devices, this involves compliance with the MDR or IVDR, which encompasses requirements for device safety, clinical efficacy, and quality assurance. The certification process ensures that medical devices are safe for use and perform as intended within their specified applications.
Saray Ugidos Seman, Head of Clinical, Regulatory, and Quality Affairs at Aura Health, emphasizes that a structured approach to CE certification is crucial for ensuring compliance and market access. She advises that manufacturers should integrate regulatory planning early in the product development phase to avoid delays and complications.
Classify your medical device
Medical devices are categorized based on risk, duration of use, and invasiveness, as outlined in Annex VIII of the MDR. The classifications are:
Class I: Low-risk devices (e.g., non-invasive instruments).
Class IIa: Medium-risk devices (e.g., surgical clamps).
Class IIb: Higher-risk devices (e.g., long-term corrective contact lenses).
Class III: High-risk devices (e.g., implantable pacemakers).
Accurate classification is crucial as it determines the conformity assessment route and the involvement of a Notified Body. Misclassification can lead to regulatory setbacks and potential market access delays.
Identify applicable regulatory requirements
Depending on the device classification, manufacturers must adhere to specific regulatory pathways:
Class I Devices: Typically, self-declaration is sufficient, provided the device is non-sterile and has no measuring function. Class IIa, IIb, and III Devices: Require assessment by a Notified Body, which involves a thorough evaluation of the device’s technical documentation and quality management systems. Compliance with harmonized European standards (EN standards) is recommended, as these provide a presumption of conformity with the MDR’s General Safety and Performance Requirements (GSPR).
Develop technical documentation
Technical documentation serves as evidence of a device’s conformity with regulatory requirements and must include:
Device Description: Detailed information on the device’s design, intended use, and variants. Design and Manufacturing Information: Specifications, drawings, and details of manufacturing processes. Risk Management: A risk analysis following ISO 14971, identifying potential hazards and mitigation strategies. Clinical Evaluation: Data demonstrating clinical safety and performance, which may include literature reviews, clinical investigations, or both. Usability Engineering: Analysis ensuring the device’s design minimizes user-related risks, following IEC 62366-1. Labeling and Instructions for Use: Compliance with MDR requirements for information provided to users. This documentation must be meticulously maintained and readily available for review by regulatory authorities or Notified Bodies.
Saray Ugidos Seman highlights that an effective Quality Management System (QMS) is the foundation of regulatory success. She recommends that manufacturers not only comply with ISO 13485:2016 but also implement proactive risk management and continuous improvement strategies to align with evolving regulatory expectations
A QMS, typically aligned with ISO 13485:2016 standards, is essential for ensuring consistent product quality and regulatory compliance. Key components include:
Document Control: Procedures for managing quality documentation. Supplier Management: Qualification and monitoring of suppliers. Production Controls: Validation of manufacturing processes to ensure product consistency. Corrective and Preventive Actions (CAPA): Systems to address non-conformities and implement improvements. Internal Audits: Regular assessments to verify QMS effectiveness. An effective QMS facilitates compliance and improves operational efficiency.
Conduct a conformity assessment
The conformity assessment process varies based on device classification:
Class I Devices: Manufacturers can self-declare conformity by compiling a Declaration of Conformity and affixing the CE mark. Class IIa, IIb, and III Devices: Involvement of a Notified Body is mandatory. The assessment may include: Quality System Audits: Evaluation of the manufacturer’s QMS. Technical Documentation Review: Detailed examination of the device’s technical files. Type Examination: Verification that a representative device sample meets regulatory requirements. Product Verification: Testing to confirm that devices conform to the approved design. Successful completion of the conformity assessment allows the manufacturer to issue a Declaration of Conformity and affix the CE mark to the device.
Register the device and manufacturer
Post-certification, manufacturers must:
Register the Device: Input device information into the European Database on Medical Devices (EUDAMED), enhancing transparency and traceability. Appoint an Authorized Representative: Non-EU manufacturers must designate an EU-based representative responsible for regulatory compliance. These steps are crucial for legal market entry and post-market surveillance activities.
Saray Ugidos Seman stresses the importance of a comprehensive post-market surveillance system to detect and mitigate risks promptly. She advises that manufacturers establish clear reporting mechanisms and conduct real-world performance monitoring to ensure patient safety and regulatory compliance.
Continuous monitoring of device performance is mandated under the MDR. Manufacturers should:
Collect and analyze post-market data to detect potential risks. Implement a Post-Market Clinical Follow-up (PMCF) plan for high-risk devices. Report serious incidents and safety-related corrective actions to relevant authorities. Maintain a Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices. These activities ensure ongoing compliance and help protect patient safety.
References
European Parliament and Council of the European Union. Regulation (EU) 2017/745 on medical devices. Official Journal of the European Union. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 Official Journal of the European Union.
European Parliament and Council of the European Union. Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Official Journal of the European Union. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746 Official Journal of the European Union.
International Organization for Standardization (ISO). ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes. Available at: https://www.iso.org/standard/59752.html
International Organization for Standardization (ISO). ISO 14971:2019 – Medical devices – Application of risk management to medical devices. Available at: https://www.iso.org/standard/72704.html
European Commission. EUDAMED Database – European Database on Medical Devices. Available at: https://ec.europa.eu/tools/eudamed
International Electrotechnical Commission (IEC). IEC 62366-1:2015 – Application of usability engineering to medical devices. Available at: https://webstore.iec.ch/publication/22749