On 22 July 2026, TÜV NORD Scandinavia Medical Notified Body AB entered bankruptcy proceedings, shortly after being acquired from RISE. According to Bolagsverket, the Swedish notified body has now ceased operations. For manufacturers, it is a reminder that notified body capacity is not just a regulatory issue, it is also a business continuity risk.
For manufacturers depending on a notified body for CE marking, this is more than industry news. It is a reminder that even the notified body relationship needs to be managed like any other critical dependency — with visibility, alternatives, and a plan if things change faster than expected.
What a notified body actually does
Under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746), most medical devices cannot be placed on the EU market without an independent conformity assessment by a notified body. In simple terms, the notified body checks whether the manufacturer’s quality management system, technical documentation, clinical evidence and supporting processes meet the legal requirements.
Only after that assessment can the manufacturer affix the CE mark and sell the device in the EU. That makes notified bodies a gatekeeper for market access — but not a public authority. They are designated and overseen by the EU Commission and national competent authorities, yet they operate as commercial organizations. They compete for customers, set fees, manage capacity and, ultimately, need a viable business model, which has shown to sometimes be challenging.
What this means, if it's your notified body
If your notified body stops operating, your CE certificate does not necessarily become invalid overnight. But it is not something to watch passively from the sidelines. The practical response is to move early, document carefully and avoid relying on assumptions.
- Confirm the certificate status directly with the relevant national competent authority.
When a notified body’s designation is withdrawn or the body ceases operating, the national authority (in Sweden’s case, Läkemedelsverket) and the European Commission are the authoritative sources on what happens to certificates already issued and any transition period granted. - Start identifying a new notified body immediately — don’t wait for a deadline.
In this situation, existing certificates need to be transferred to a new notified body. Even if a grace period applies (9 months, with an option for another 3 months), it comes with strict conditions; (1) It is intended to allow for reassessment and transfer activities to be performed by the new NB — meaning that manufacturers need a signed agreement with a new NB for the grace period to apply. (2) Devices deemed by the national CA to represent a safety issue may be denied a grant period and at risk of losing their certificate.
=> Do choose your Notified Body carefully but start the transfer process as soon as possible, to reduce the risk of a gap in market authorisation.
- Use the voluntary certificate transfer process, not a fresh application.
Most notified bodies offer a defined pathway for taking on customers whose previous notified body can no longer support them. This typically involves the incoming notified body reviewing your existing technical documentation and certification history, a transfer agreement between you, the incoming body, and (where possible) the outgoing body, and a supplementary audit rather than starting the conformity assessment from zero. Ask prospective notified bodies specifically about this pathway — it’s usually faster and cheaper than a new application. - Secure your documentation now, independent of the notified body.
Technical files, audit reports, evidence of substantive changes communicated to your notified body, and your certificate history need to be in your own hands — don’t assume you can retrieve them later from an organisation that’s winding down. Under MDR/IVDR, retention obligations run for 10 years after the last device is placed on the market (15 years for implantables), so this is your responsibility regardless of what happens to the notified body. - Loop in your EU Authorised Representative and distributors early.
If you are a non-EU manufacturer and your certificate status is at risk of a gap, your Authorised Representative, importers, and distributors need to know before regulators or customers find out some other way. This is also a good moment to review your own contingency documentation — who’s responsible for maintaining records if a business relationship in your supply chain is disrupted.
The bigger picture
Situations like this bring back a larger debate that has been running since MDR came into force: is it sustainable to base market access for medical devices on a limited pool of private certifiers, many of whom may be under significant operational and financial pressure?
That question can and will not be solved by individual manufacturers. What manufacturers can do, however, is reduce their own exposure. Keep documentation portable. Stay close to your notified body but keep yourself informed about their status (even financial status) and keep an eye on, or even look out for, potential alternatives to establish preparedness in case of disruption. Treat notified body selection as an ongoing risk-management decision, not a box that was ticked once at the start of certification.