What is a Notified Body IVDR?
A notified body IVDR is an organization designated by an EU Member State or other countries under specific agreements to assess the conformity of certain products before being placed on the market to requirements and using the procedures specified in the legislation.
The MHRA is an example of a non-EU Competent Authority (CA) as they are the CA for Northern Ireland following BREXIT.
Notified Bodies are independent third parties paid by the manufacturer to review the manufacturers' technical documentation and quality management system as required by the IVDR.
Which Notified Body IVDR is designated?
As independent third-party conformity assessment organizations, Notified Bodies must demonstrate that they are independent, impartial, and technically competent. They are designated following a review of their processes and procedures, focusing on the competence of all staff. Notified Body reviewers typically have over five years of experience with particular devices and often have a Ph.D.
Individual technical experts and auditors are assigned codes based on their academic and technical expertise. Manufacturers are also coded so that reviewers can be matched to specific projects. Technical file reviews are always a team effort and will include clinical experts, as well as a final independent certification peer review by an independent person.
The
Commission webpage for Notified Bodies offers a link to the NANDO website that contains a list of all Notified Bodies designated to 2017/746, including their scope and codes for which the Notified Body is designated.
When to contact the Notified Body IVDR?
Notified Bodies must remain independent and impartial, and as a result, they are unable to provide consultancy. It is, therefore, important to approach your Notified Body with a position and not ask for their advice. Notified Bodies are allowed to have "structured dialogues." this can be useful when you have a novel device, and you need to confirm classification or your proposed approach to meeting the requirements. The manufacturer must present a position the Notified Body is not allowed to determine the classification for you or tell you how many patient samples you need in a study.
Qserve has several members of staff who held senior positions at Notified Bodies who can help you prepare for these meetings to get the most out of the opportunity.
Engaging with a Notified Body is important before you start writing your technical documentation. Notified Bodies provide guidance on how they would like technical files to be presented; some Notified Bodies will have portals for uploading documentation, so their directions on how to present a file should be followed when constructing files.Interested in Qserve Notified Body IVDR support?
Do you want more information, need assistance with selecting a Notified Body, or need to compile or review your technical files? Qserve is here to help with your needs.
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What are the challenges for manufacturers?
Manufacturers face the following challenges:
- Selecting a Notified Body
- Applying to a Notified Body
- 50% of applications are not compliance at the initial application
- Writing a compliant technical file
- Responding to technical file questions
- Hosting a Notified Body audit, including unannounced audits
- How to efficiently address non-conformities
Our consultants offer expertise based on years of experience in guiding clients. With former employees of Notified Bodies on board, we understand the challenges of manufacturers like no other. Contact us for professional guidance towards a Notified Body.
Qserve Notified Body support
As Notified Bodies cannot provide consultancy, we use our notified body experience to bridge the gap. Services available include:
- Selecting the most appropriate Notified Body for you
- Notified Body applications,
- Training on how to write a compliant technical file
- Technical file preparation
- Effectively answering notified body questions
- Training on how to host a Notified Body audit, including unannounced audits
- How to respond to non-conformities or specific compliance issues.
Many manufacturers are familiar with working with their Notified Body as their IVDR auditor but are not prepared for the rigors of a technical file review. We can help you prepare and facilitate an effective relationship with your notified body.
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Notified Body capacity
When the IVDR was implemented, there was a significant increase in devices requiring Notified Body oversight, from approximately 20% to over 90%. In addition, the process of designating Notified Bodies was very slow, resulting in restricted Notified Body capacity. This situation is improving, and the Commission regularly surveys Notified Bodies to determine their capacity. The latest survey results can be found on the Commission's Notified Body page.
This situation is dynamic, and availability will reduce as submission deadlines approach, so it is important to monitor availability and have a regular dialogue with your Notified Body. Reviews can take an average of 18 months.
How to achieve IVDR compliance?