ANSWERED ON THIS PAGE:
- What is the EU CE Mark and what does it mean?
- What is the medical device CE Marking process for Europe?
- Who is responsible for maintaining regulatory compliance in Europe?
What is CE Marking for medical devices?
To sell medical devices in the European Union (EU), you must obtain CE Marking for your product. CE Marking indicates that your medical device complies with applicable EU regulations, and enables the commercialization of your products across all EU member states. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation. Manufacturers of in vitro diagnostic (IVD) medical devices must meet similar requirements for CE Marking in Europe.
With offices throughout Europe, Emergo's regulatory experts can help you obtain CE Marking for your medical device and start selling your product in the EU.
How to obtain European CE marking for your medical device
CE is not a quality mark, but compliance with the EU Medical Devices Regulation (MDR 2017/745) requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. We have a detailed chart explaining the current European CE approval process for medical devices here. However, the basic process follows these steps:
- Determine whether your product meets the definition of a medical device according to the MDR.
- Determine the classification of your device. See our chart.
- Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
- Prepare a CE Marking Technical File or a Design Dossier.
- Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDR.
- Select and appoint a European Authorized Representative (EC REP) to act on your behalf within the EU if you have no physical location in Europe.
- Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile, and has no measuring function.
- Obtain CE Marking and ISO 13485 certificates from your Notified Body.
- Prepare a Declaration of Conformity (DoC), which states that your device complies with the MDR.
For additional information on EU Medical Devices Regulation compliance, download our MDR white paper.
Emergo can help you obtain EU CE Marking for your medical device
Emergo has a well-established presence in the EU with offices in the UK, Germany, France, and The Netherlands. We have assisted hundreds of medical device manufacturers with CE compliance for Europe. Our services include:
- Assistance with product classification
- Verification of applicable standards and testing requirements
- Technical File or Design Dossier compilation, or review of your files
- Review of existing marketing materials, labeling, and user manual information to ensure compliance and consistency
- Verification of compliance with Essential Requirements
- Preparation of Clinical Evaluation Report based on provided clinical data
- Implementation, modification, and maintenance of a quality system (usually ISO 13485) that will meet European and other international requirements
- Authorized Representative services in Europe
- Risk assessment and management (ISO 14971)
- Development of vigilance and post-market surveillance procedures
Contact us to learn how we can help you obtain CE marking for your medical device in Europe.
Frequently asked questions about CE Marking
How long is a CE certificate valid?
Under the current system, CE certificates issued by Notified Bodies are generally valid for three years. The validity period may only be one year for some high risk devices. However, the status of your CE certification is dependent on 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 prior to final implementation of the MDR have a maximum validity of five years. However, all CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force.
Who will issue my CE Marking certificate?
If your medical device is Class I (provided sterile or has a measuring function), Class IIa, IIb, or III, or if your IVD falls under Annex II, List A; Annex II, List B, or is self-testing, you will receive a CE certificate from a Notified Body. Class I non-sterile, non-measuring devices and general/other IVDs may be self-certified and do not require a CE certificate from a Notified Body.
Does the Notified Body name appear on my product labeling?
Their name will not appear but their four-digit NB number will appear under the CE Mark symbol on your labeling.
Will changing a contract manufacturer impact my CE certification?
Yes, because this is a change in critical suppliers. In this situation, Legal Manufacturers (i.e., "owners" of the CE marking) will select a new contract manufacturer based on criteria outlined in their quality system, which should describe how to qualify and continually assess their suppliers.
The Legal Manufacturer must notify their Notified Body of this change and request an updated CE certificate. The Notified Body may require an onsite audit of the new contract manufacturer to issue an updated CE Certificate.