The author reviews the conformity assessment process contained in Annexes VII, II, V, and III related to a company seeking CE Marking regulatory approval.
CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier)—regardless of the device classification. However, the classification of the device has a significant impact on the regulatory approval pathways available to your company. Therefore, the first step in the process of CE Marking of medical devices is to determine the risk classification (http://bit.ly/riskclass). There are four device classifications: Class I, IIa, IIb, and III.
Once your company has determined the risk classification of the device, then you must determine which conformity assessment procedure you will follow to receive CE Marking approval. The conformity assessment procedures available for each classification are identified in Article 11 of the Medical Device Directive (http://bit.ly/M5MDD), and additional detail is provided in the various Annexes (i.e., – Annex II, III, IV, V, VI, and VII). The following table below summarizes the options for each classification:
If your product is a Class I device that is non-sterile and non-measuring, then you will not require a Notified Body (NB). However, all other products will require your company to select a NB (http://bit.ly/SelectingRegistrar).
Annex VII – Declaration of Conformity
If your company does not require NB involvement, then you will be able to issue a Declaration of Conformity In accordance with Annex VII. You will also need to register your product with one of the Competent Authorities (CA) in Europe. CAs are the U.S. FDA equivalent in each EU member state. The following is a list of contact information for all the CAs: http://bit.ly/ContactPoints. If your company does not have a physical presence in Europe, you will also need to select a European Authorized Representative (AR). My recommendation is to select an AR that is one of the 15 members of the European Association of Authorized Representatives (http://bit.ly/EAARMembers).
Annex II – Full Quality Assurance
Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity and also reviews your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls and that your process for establishing and maintaining a Technical File is adequate. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the Certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.
Annex V – Production Quality Assurance
The Annex V conformity assessment process is the most common route to CE Marking for companies that outsource product design to a third-party. If your company outsources design, Clause 7.3 is excluded from your ISO 13485 Certification, and you cannot demonstrate “Full Quality Assurance.” Therefore, the NB will issue an Annex V certificate for “Production Quality Assurance.” Annex IV and Annex VI are alternate conformity assessment procedures, but these are used less frequently for medical devices and are outside the scope of this blog.
Annex III – Type Examination
The Annex III conformity assessment process is a type of examination that is performed for higher risk devices where the company does not have an Annex II certificate. This type of examination involves a review of your company’s design dossier, and the NB issues a Type Examination CE Certificate. This Certificate cannot be used alone for CE Marking. Type Examination Certificates must be used in conjunction with another CE Certificate, such as the Annex V certification for Production Quality Assurance. This combination would be used for Class IIb and Class III devices in place of an Annex II CE Certificate.
If your company needs help with CE Marking, including training on the medical device directive, please contact Medical Device Academy at rob@13485cert.com. We are also developing a webinar series for this purpose. If you interested in more services, try viewing the following blog category page: http://bit.ly/CEMarking.
Hello Rob
I do not understand the last statement under Annex II: ” Once you have the certificate, your company will be able to launch new products without prior approval from the NB.”
are you referring to the quality system certificate?
Prior launch of new product the NB must review and approve the technical file and issue a CE certificate to the new product (or add it to the schedule of the existing CE certificate?
thanks
Nimrod
The Annex II.3 certificate issued is called a “Full Quality System” certificate. It is not a product certificate. The scope of the certificate could be written to be device specific, but usually it is written to be more generic to cover a family of devices. For example, “Design and manufacturing of sterile, disposable minimally invasive surgical devices and accessories.” A scope with this breadth can cover a large variety of products. The company would “add [new products] to the schedule of the existing CE certificate” simply by notifying the NB that there is a new or revised Declaration of Conformity and a new or updated Technical File. No pre-approval is required, because these devices are Class IIa and within the existing scope of activities.
If the new device is outside the scope, then an extension to scope and re-issue of the CE Certificate is required. A review of a Technical File is needed, but this review could be part of the next scheduled visit by the NB or it could be a desk-top audit of the new Technical File. This is why Notified Bodies need to be careful in the wording of the scope for CE Certificates, and this is how some companies run into trouble when they fail to notify the NB of significant changes.
Pingback: CE Marking Approval of Medical Device Medical Device Academy