In order to sell medical devices and IVDs in the European Union, you must first CE Mark your product. The CE Mark is not a quality mark, nor is it intended for consumers. CE marking indicates to EU regulators that your device meets all applicable requirements of the appropriate EU Directive, such as the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD), as they apply to your product.
How to obtain CE marking for your medical device or IVD
As a medical device legal manufacturer, you are solely responsible for maintaining compliance with the applicable EU Directives and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.
European CE marking requires the following steps:
- Prepare a CE Marking Technical File or a Design Dossier (for a Class III device) that includes data demonstrating compliance with the applicable directives (MDD, IVDD, AIMD).
- Establish and maintain a compliant Quality Management System (typically by implementing ISO 13485) if your medical device is class I provided sterile or has a measuring function, Class IIa, IIb, III, or an active implantable medical device, or if your IVD falls under Annex II, List A; Annex II, List B, or is self-testing.
- Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
- Obtain your CE (and QMS) certificates from a Notified Body, if applicable, or self-certify your compliance with the MDD (Class I non-sterile, non-measuring devices) or IVDD (general/other IVDs).
NOTE: This is an extremely abbreviated version of the CE marking process. To see a more detailed explanation, download our CE chart explaining the regulatory process in Europe.
Let Emergo assist you with CE compliance
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 compliance in Europe. Our services include:
- Assistance with product classification and identification of applicable standards for your medical devices
- Medical device and IVD CE Marking Technical File or Design Dossier compilation and review
- Verification of Essential Requirements
- 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
Please contact us for more information on how we can help you obtain CE marking for your medical device or IVD in Europe.
Frequently Asked Questions
How long is a CE certificate valid?
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, your CE certification is dependent on maintaining your quality system certification.
Who will issue my CE Marking certificate?
If your medical devices is Class I with 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?
If Notified Body involvement is required, their four-digit number will appear below the CE Mark symbol.
Will changing a contract manufacturer impact my CE certification?
Yes, since this means there is a change in critical suppliers. In these situations 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 outline how to qualify (and continually assess) their suppliers. And, the Legal Manufacturer will need to notify their Notified Body of this change, as it's considered significant, and have an updated CE certificate issued. The Notified Body may require an onsite audit of the new contract manufacturer prior to issuing an updated CE Certificate.