European CE Marking Strategy for Medical Devices
The CE mark for medical devices ensures regulatory compliance for entry into Europe, and Operon Strategist, a leading EU MDR consultant, supports numerous manufacturers in achieving CE compliance across the EU.
What is the EU CE Mark and What Does it Mean?
The CE Mark indicates that your medical device complies with applicable EU regulations, facilitating the commercialization of your products across all EU member states. As a legal manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, whether you handle all manufacturing operations in-house or outsource components. This applies equally to manufacturers of in vitro diagnostic (IVD) medical devices.
The CE Marking Process for Medical Devices in Europe
Compliance with the EU Medical Devices Regulation (MDR 2017/745) requires meeting specific standards of performance, quality, safety, and efficacy. The CE marking process generally includes:
- Defining Your Product: Confirm that your product meets the definition of a medical device per the MDR.
- Device Classification: Determine the classification of your device.
- Quality Management System (QMS): Implement a QMS, commonly ISO 13485, applicable to your device.
- Technical Documentation: Prepare a CE Marking Technical File or a Design Dossier.
- Clinical Evaluation: Develop a Clinical Evaluation Report (CER) as per MEDDEV 2.7/1 rev4 and MDR.
- Authorized Representative: If you have no physical location in the EU, appoint a European Authorized Representative (EC REP).
- Notified Body Audit: Your QMS and Technical File/Design Dossier must be audited by a Notified Body, unless your device is Class I, non-sterile, and non-measuring.
- Certification: Obtain CE Marking and ISO 13485 certificates from your Notified Body.
- Declaration of Conformity (DoC): Draft a DoC stating your device’s compliance with the MDR.
Streamline Your EU Technical Documentation with Operon Strategist
Operon Strategist offers comprehensive services to help you secure CE marking, including:
- Product classification assistance
- Verification of standards and testing requirements
- Compilation or review of Technical Files or Design Dossiers
- Review of marketing materials, labeling, and user manuals for compliance
- Essential Requirements compliance verification
- Clinical Evaluation Report preparation
- Implementation and maintenance of quality systems (ISO 13485)
- European Authorized Representative services
- Risk assessment and management (ISO 14971)
- Development of vigilance and post-market surveillance procedures
To explore how Operon Strategist can support your CE marking journey, contact us at enquiry@operonstrategist.com or via WhatsApp.
We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran. For free consultation Contact us now.
Frequently Asked Questions about CE Marking
How long is a CE certificate valid? CE certificates issued by Notified Bodies are generally valid for three years, but for some high-risk devices, the validity may only be one year. Your certification status is contingent upon maintaining your quality system certification.
Our device already has CE Marking. How does MDR 2017/745 affect our status? The MDR came into full effect in May 2021. Certificates issued before the MDR’s implementation have a maximum validity of five years but will expire four years after the MDR comes into force.
Who issues my CE Marking certificate? Notified Bodies issue CE certificates for Class I (provided sterile or has a measuring function), Class IIa, IIb, III medical devices, and certain IVDs. Self-certification is allowed for non-sterile, non-measuring Class I devices and general/other IVDs.
Does the Notified Body name appear on my product labeling? The Notified Body’s four-digit NB number appears under the CE Mark symbol on your labeling, not their name.
Ensure smooth and compliant entry into the European market. Contact Operon Strategist today to learn how we can assist you in obtaining CE marking for your medical device.