Medical devices
In order to place their products on the European market, manufacturers of medical devices must obtain a valid certification issued by a designated Notified Body. This guide explains what to consider when changing your Notified Body, and how TÜV NORD can support you to ensure a smooth and safe transition.
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Having a reliable Notified Body is essential to maintaining market access and ensuring uninterrupted certification of your medical devices. Some reasons why manufacturers consider a change include a lack of transparency or expertise, or the desire to have multiple certified group entities and other certifications (e.g. ISO 13485) under a single Notified Body. In today´s regulatory environment, which is shaped by the new MDR and IVDR requirements and new ongoing updates, it is important to have a reliable certification partner that will ensure that your products meet all the requirements of the market.
TÜV NORD can help you achieve all this. We are one of the most experienced Notified Bodies in the field of medical device certification and conformity assessment. Our team of experts help protect your product´s quality and strengthen their reputation on the market through structured processes and innovative solutions.
To switch to a new Notified Body, you will need to sign a tripartite transfer agreement with the current and the new NB. This agreement regulates disclosure, facilitates the exchange of documentation and defines sell-off periods for devices. All Notified Bodies are obliged to support the transfer.
Timing is one of the most crucial factors to consider. We strongly recommend contacting the new Notified Body well in advance of the intended transfer or the expiry of the existing certificate to allow sufficient time for planning and a smooth transition. Moreover, the new Notified Body checks further documentation such as applications, audit and technical file assessment reports, and copies of certificates in an on-site transfer audit. Thus, this lead time allows for proper planning, document review, and scheduling of audits without putting existing certificates at risk.
We strongly advise not to stop any ongoing certification activities with your current Notified Body until the transfer is successfully completed.
Interrupting existing processes can lead to certificate gaps, and potential market disruptions. The safest approach is to continue working with your current Notified Body while the new Notified Body prepares the transfer.
After approval of the transfer audit, the new Notified Body issues a certificate with the remaining validity duration as before. This certificate is entered into EUDAMED database.
The Notified Body sets up an audit program and plans the regular surveillance audits where previous non-conformities can be followed up. At the same time, a sampling plan is established to identify the technical documentations or PMS data to be submitted for review.
When changing Notified Bodies, the identification number displayed next to the CE mark also changes. It is important that this change is properly documented and clearly linked to specific production batches. The transfer agreement will define the sell-off period of devices labeled with the mark of the former NB (Designation scope TÜV NORD CERT at NANDO).
Recent guidance in form of a position paper on the Agreement related to the transfer of MDR formal application and of appropriate surveillance of legacy devices provides additional and more specifying information about the planning of a Notified Body change. The position paper confirms that an MDR formal application can be transferred under certain conditions. During the transfer period the surveillance of all legacy devices must remain uninterrupted in order to maintain active certification before the new Notified Body has fully taken over.
Finally, to benefit from this scheme, organizations must engage their new notified body early, ensure their documentation is complete, and maintain audits with their current notified body.
Please also note that, in accordance with MDR Article 120, as amended by Regulation (EU) 2023/607, manufacturers need to ensure that a formal MDR application has been submitted, and certification is completed before the end of the applicable transition period (31.12.2027 for class IIb implantable and class III devices; 31.12.2028 for class Isrm, IIa devices and sterile procedure packs).
If you are also interested in transferring your ISO 13485 certification, this process can be completed simultaneously without incurring additional costs.
