Notified / Approved Body Engagement
If you are planning to launch your product in the UK or EU, you will need to engage an independent Notified Body (EU) or Approved Body (UK) who will be responsible for reviewing and certifying your product.
Conformity assessment procedures of certain medical device products (including software) may need the involvement of third-party, independent bodies. In the EU, these organisations are called Notified Bodies and their role is to evaluate whether the product complies with European legislation before they grant a CE mark. In the UK, such organisations are called Approved Bodies, and they are similarly responsible for evaluating regulatory submissions for granting UKCA marks.
With the exception of Class I devices a Notified Body/Approved Body must be involved in the approval and certification of all medical devices that fall within the scope of the EU MDR/UK MDR. For example, in the case of Medical Device Software which presents risk factors (Class Im, Class IIa, Class IIb and Class III), certification by a Notified Body/Approved Body is required. In other cases of Software as Medical Devices with low risk (Class I), engagement with Notified Body/Approved Body is not required as the product can be self-certified for market access.
Best Practices
Align with internationally recognised standards.
A list of Notified Bodies from each Member State can be found in the European Commission NANDO database. Similarly, The UK government also keeps a list of UK Approved Bodies that can be engaged for varying medical device types. Remember that you may need to engage both a UK Approved Body and an EU Notified body if you are intending to have both UKCA and CE marking. Whilst the UK will accept CE-marked devices which received their certification before June 2024, this will not be the case after that cutoff.
Notified bodies are in high demand, and waiting for an audit date can take several months. Therefore, the best practice is to engage in the process early, so that audit dates can be planned well in advance. This will give your company the necessary time to prepare and develop the product and associated documentation.
Case Study
How Hardian solves the problem.
Hardian Health has supported many clients such as Neuronostics in the selection process of a Notified Body/Approved Body. We do this by carefully taking into consideration the qualification and classification of the Client’s product, the technical competence of the body, the waiting time prior to starting formal assessment by the body, the duration of the certification process as well as the structure of the fees for the various stages of certification.
We are highly experienced through interactions with a wide range of Notified Bodies/Approved Bodies. Based on estimated wait times, we can advise on the best time for engagement with regulatory bodies during your product lifecycle, and facilitate any liaison/communications with the notified body as well.
Get in touch
Getting healthtech to market doesn’t have to be difficult.