MDR Notified Body Designation: How It Works and How to Find a Designated Body

How MDR notified body designation works

Designation under the MDR is a formal procedure set out in Articles 35 to 46 of Regulation (EU) 2017/745:

1. National authority. Each Member State that designates notified bodies appoints an authority responsible for notified bodies (Article 35). The conformity assessment body applies to that authority.
2. Joint assessment. The application is assessed by the national authority together with a joint assessment team of, as a rule, three experts: one from the Commission, who coordinates, and two from other Member States (Article 39). The MDCG then issues a recommendation.
3. Notification in NANDO. The Member State notifies the designation through NANDO, the Commission's database of notified bodies. The notification states the scope using the designation codes (Article 42). Other Member States and the Commission have 28 days to object.
4. Designation becomes valid. It becomes valid the day after the notification is published in NANDO, and the body may act as a notified body only from that day (Article 42(11)-(12)). The Commission assigns it a four-digit identification number (Article 43). Bodies notified under the old directives keep their existing number.
5. Ongoing monitoring. The national authority re-assesses each notified body at least once a year, including an on-site audit. A complete re-assessment with a joint assessment team takes place three years after notification and every fourth year after that (Article 44). Extending the scope requires the same assessment and notification procedure (Article 46).

How to check whether a notified body is designated under MDR

1. Open NANDO and select the legislation Regulation (EU) 2017/745 on medical devices. A designation under the old directives (93/42/EEC, 90/385/EEC) is not an MDR designation.
2. Open the body's entry and check its designation scope: the MDA/MDN codes (device types), the MDS/MDT codes (horizontal and technology codes from Implementing Regulation (EU) 2017/2185) and the conformity assessment annexes it may apply.
3. Check for limitations or conditions in the notification. A body can be designated but restricted for some codes, device classes or annexes.
4. Confirm availability directly. Designation shows what a body may assess, not whether it is accepting new clients. See the NB Capacity Tracker for the capacity status of major MDR notified bodies.

When do you need an MDR Notified Body?

Under MDR 2017/745, most medical devices require third-party conformity assessment by a Notified Body (NB). Self-declaration without NB involvement is permitted only for Class I devices that are not sterile, have no measuring function and are not reusable surgical instruments. Class Is, Im and Ir devices need an NB for those aspects only; Class IIa, IIb and III devices need a designated NB.

Notified Bodies under MDR are officially designated by EU Member States and listed in the Commission's NANDO database. Each NB has a specific designation scope — not every NB covers every device type, class or MDR designation code. Finding one with both current capacity and the right designation scope is the main challenge manufacturers face.

Which device classes require an MDR Notified Body?

Why finding an MDR Notified Body is difficult

MDR Notified Body capacity has been severely constrained since 2021. Many NBs have waitlists, restricted scopes, or are not accepting new clients for certain device categories. Searching EUDAMED manually and contacting NBs one by one is time-consuming and often results in rejections or no response.

Designation scope is coded with the MDR codes of Implementing Regulation (EU) 2017/2185 (MDA/MDN, MDS and MDT codes) — matching your specific device to an NB with the right scope requires detailed knowledge of the designation system.

How to prepare the request

Describe your device type, classification, EMDN code and the applicable MDR designation codes, target markets and current documentation status. A prepared request can be sent to Notified Bodies that have indicated availability and whose designation scope matches your product.

You receive NB responses directly with scope confirmation, estimated timelines and next steps — without cold outreach or manual EUDAMED searches.

Frequently asked questions

What does "designated under MDR" mean?

It means a Member State's authority has assessed the body together with a joint assessment team, notified it through NANDO, and the notification has been published. Only then can the body issue MDR certificates, and only within the scope listed in its notification.

Where can I find the list of MDR designated notified bodies?

The official and current list is in NANDO, filtered by Regulation (EU) 2017/745. The number of designated bodies changes as new designations and scope extensions are published, so check NANDO rather than a static list.

Is a notified body under the Medical Devices Directive also designated under MDR?

Not automatically. Bodies notified under Directives 93/42/EEC or 90/385/EEC had to go through the full MDR designation procedure. If designated, they keep their identification number, but the MDR scope can differ from their old directive scope.

What are MDR designation codes?

They are the codes from Implementing Regulation (EU) 2017/2185 that define what a body may assess: MDA and MDN codes for device types, MDS codes for horizontal characteristics such as sterility or software, and MDT codes for technologies and processes. Your device has to be covered by the body's codes.

How long does MDR notified body designation take?

The MDR sets deadlines for individual steps, such as 28 days for objections after notification and 42 days for publication in NANDO. The whole procedure, including the joint assessment, has in practice often taken well over a year.