In Europe, the review and approval of medicinal products involve Medicinal Competent Authorities from A to Z, the review and approval of medical devices and in-vitro diagnostics devices, however, follow a different path, with the involvement of another type of organization called “Notified Bodies”, which are responsible for the CE certificate issuance.
This is quite different from other geographical areas: for example, in the United States of America, the FDA is the public federal agency that reviews and gives the final approval for medicinal products, and medical devices, and in-vitro diagnostics.
Who are those Notified Bodies? How many are there? Are Manufacturers forced to choose the Notified Body of the country where they are located? How and when should you engage with Notified Bodies? Which one would be best to submit your technical dossier to get the CE-marking?
I. What is a Notified Body?
A Notified Body is a private organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is required. The European Commission publishes a list of such notified bodies.
Those bodies can be notified of several regulations (European Directives or European Regulation) depending on the sector (or multiple sectors) they are operating in personal protective equipment, construction products, pressure equipment, etc. Among those sectors are medical devices and in-vitro diagnostics devices: Directives 93/42/EEC, 90/385/EEC, and 98/79/EC now being replaced by Regulation (UE) 2017/745 and 2017/746. The full scope of notification of the Bodies (also called “scope of the designation”) to the different Directives or Regulation can be found on the NANDO website which is regularly updated (either for new notifications, an extension of the scope of notification, suspension or termination of some bodies).
Each Notified Body is identified by four-digit numbers on the NANDO website. For medical devices requiring to be reviewed by a Notified Body, the CE-mark symbol on documents (and on the devices themselves) will be followed by the four-digit numbers corresponding to the Notified Body which conducted the review and issued the CE certificate. Indeed, for self-certified devices, the CE symbol will not contain any digit numbers.
II. Does that mean that a Notified Body can only be located in the EU?
Due to some mutual recognition agreements or treaties with the European Union, other entities outside of the EU can operate as Notified Bodies. Thus, SQS (Switzerland), the TGA (Australia), TSE (Turkey) are Notified Bodies designated among the 54 Notified Bodies, for the Directive 93/42/EEC.
Moreover, although being headquartered in the EU, Notified Bodies can have a subsidiary outside the EU, to better serve their international clients.
III. Do all European Union Member States have a Notified Body?
Some countries don’t have a Notified Body for Directive 93/42/EEC (e.g. Austria, Bulgaria, Croatia…) and it is even more critical for Directive 98/79/EC with only 13 Member States having at least one Notified Body (including the United Kingdom).
IV. What does it represent in terms of figures?
54 Notified Bodies designated for Directive 93/42/EEC.
12 Notified Bodies designated for Directive 90/385/EEC.
22 Notified Bodies designated for Directive 98/79/EC.
17 Notified Bodies designated for Regulation (UE) 2017/745.
4 Notified Bodies designated for Regulation (UE) 2017/746.
V. Can any Notified Body assess the technical documentation of my product?
As we discussed earlier, the first step is to ensure the Notified Body is designated for the appropriate Directive/Regulation. Naturally, if the product is an in vitro diagnostics device, the Notified Body should be designated for the Directive 98/79/EC or the Regulation 2017/746.
The second step is to check if the category of the product can be found in the scope of notification of the Notified Body: e.g. if the product is a non-sterile wound dressing (that would not contain any medicinal product integrated within), the appropriate code related to the assessment could be MD 0301. Finally, the last step is to engage with the Notified Body regarding its availability to accept to contract for the review of the technical file.
Indeed, two deeper levels should be taken into consideration by medical device manufacturers related to the capability of Notified Bodies to assess their file:
- The conformity path they want to apply for.
- The medical category of their product.
Manufacturers have the freedom to select the conformity pathway related to the assessment of their technical file: e.g. under the Regulation 2017/745, Annex IX (Full Quality System) implies the review of the full quality management system of the medical device manufacturer in addition to the review of the technical file of the product. Depending on the risk classification of the medical device, different conformity pathways can be followed (naturally, the higher the risk classification, and the higher the level of evidence expected to demonstrate compliance).
VI. Do I have contractual obligations to have all my products certified by the same Notified Body?
As part of the submission of the technical documentation of a medical device for review as part of the CE marking, the manufacturer should not have launched the submission of the technical documentation (and contractualization) with any other Notified Bodies for that specific medical device.
Nevertheless, in the case of products in different categories (e.g. inhalators, and wound dressings), a legal manufacturer would have the freedom to contractualize with different Notified Bodies for each category.
VII. Can I transfer my products to another entity?
For medical devices, the “transfer process” is understood as transferring a CE certificate issued by a Notified Body to another Notified Body, without starting over the certification process, but without bringing any other changes to the CE certificate.
In those cases, a tripartite agreement is highly recommended with the current Notified Body, the selected Notified Body to transfer the CE certificate to, and the Legal Manufacturer. Thus, there would not be any overlap of the regulatory clearance of the medical devices to remain on the market. also, the discussions could cover the leftover transition where devices with the CE of the previous Notified Body could still be on the market (up to six months) before bearing the new CE of the new Notified Body.
The process of transfer may be billed at a different rate by Notified Bodies. Naturally, there are specific conditions for a Manufacturer to be eligible to use this process:
- The certificate should not be suspended.
- The expiration of the certificate should not occur within the six months before the transfer could occur.
- No major complaints or vigilance events since the last certification audit.
Note: as part of the requirements of the Regulation (UE) 2017/745, each Notified Body designated according to this Regulation, should made publicly available, the description of the application procedure by which manufacturers can obtain certification from it, including fees charged for specific conformity assessment activities and any other financial conditions relating to their assessment.
VIII. Is there a best-Notified Body?
Different reasons should come into consideration in the process of selecting a Notified Body (in addition to the prerequisites listed in the above sections). Besides the more technical related aspects, the language used for your Technical Documentation (and quality management system) could be a factor to consider for the ease of the Notified Body to assess the documentation.
Whereas we always speak of Notified Bodies able to issue CE Certificates, those bodies could be involved to issue opinions on the device part of a specific type of combination product prior to the submission for the medicinal marketing authorization of the medicinal product. Indeed, Article 117 of Regulation 2017/745 is amending Directive 2001/83/EC by adding this distinct step for a category of products. This reinforces strategic considerations for the selection of Notified Bodies which should be selected on the level of their expertise for the device part which will operate as a container closure system or delivery system of the combination products.
Lastly, when planning an expansion to other geographical areas and particularly to Canada, you may like to consider a Notified Body also designated into the Medical Device Single Audit Program (MDSAP). The list of Recognized Auditing Organizations to conduct audits and issue MDSAP certificates can be found on the FDA website (a few European Notified Bodies engaged in this program since its launch: e.g. DEKRA Certification B.V, NSAI, DQS Med, etc).