Notified body medical devices guide to NANDO and selection
Find a notified body for medical devices in NANDO, check its MDR or IVDR scope, and compare capacity, languages and fees before your formal application.
A notified body for medical devices is an organisation designated to perform independent conformity assessment within an authorised scope. To find one, use the Commission's NANDO register and check the exact legal entity's MDR or IVDR notification.
A familiar name is not enough. You need a body whose published scope covers your device and assessment procedure. You also need to confirm that it can accept your application. The Commission's overview explains the designation system and links to the relevant lists.
What a medical-device notified body does
Depending on the conformity-assessment route, the body assesses the manufacturer's quality system, technical documentation or both. It issues certificates and performs surveillance within its designated scope. Its role is limited to the tasks covered by that designation. See MDR Article 56 and Annex IX.
The manufacturer remains responsible for compliance. Under MDR Article 19, drawing up the EU declaration of conformity assigns that responsibility to the manufacturer. A notified-body certificate does not transfer it.
Where to find the current MDR and IVDR lists
The NANDO database now sits within the Commission's Single Market Compliance Space. Use the separate active-notification lists for MDR notified bodies and IVDR notified bodies.
On 3 November 2026, NANDO displayed 51 active MDR results and 19 active IVDR results. Recheck the live register before choosing a body. These are separate designation lists, not 70 unique organisations: a body can appear in both.
To search the register:
- Select Regulation (EU) 2017/745 for medical devices, or Regulation (EU) 2017/746 for IVDs.
- Select active notifications and click "Refine results".
- Wait for the results heading to show the intended legislation and status.
- Open the exact legal entity's record and read its notification under that regulation.
Changing a filter may not refresh the results immediately. Check the heading before using the results. The portal's all-legislation total is not a count of medical-device notified bodies.
Read the notification's device codes, procedures, annexes, conditions and exclusions. Open the notification PDF wherever the record refers to it. An MDR listing does not establish IVDR competence. MDR Articles 42–43 and IVDR Articles 38–39 provide the notification framework. The published scope matters, not just the organisation's name.
When do you need a notified body?
Not every CE-marked device needs third-party assessment. The ordinary routes depend on device class and certain characteristics, as set out in MDR Article 52 and IVDR Article 48.
| Device category | Ordinary notified-body involvement |
|---|---|
| MDR Class I, not sterile, not measuring and not a reusable surgical instrument | Normally none; manufacturer self-declaration |
| MDR Class I sterile, measuring or reusable surgical instruments | Required, limited to the relevant sterile, metrological or reuse-related aspects |
| MDR Classes IIa, IIb and III | Required under the applicable conformity-assessment route |
| IVDR Class A non-sterile | Normally none; manufacturer self-declaration |
| IVDR Class A sterile | Required, limited to sterile-condition aspects |
| IVDR Classes B, C and D | Required under the applicable route |
This table covers ordinary market-conformity routes. Custom-made devices follow MDR Article 52(8) and Annex XIII. Class III custom-made implantable devices also require notified-body involvement. Investigational devices, performance-study devices and qualifying health-institution in-house devices have separate regimes. Check MDR Articles 5(5) and 52 or IVDR Articles 5(5) and 48 before applying the table to those cases.
How to choose a notified body
Match the full designation scope
Prepare a device description, its intended purpose, risk class and proposed conformity-assessment route. Use that information to check each candidate's notification. Do not stop when one product code appears to match.
Implementing Regulation (EU) 2017/2185 sets the designation codes. Under MDR, MDA covers active devices and MDN covers non-active devices. MDS addresses specific characteristics, while MDT addresses technologies and processes. IVDR uses IVR, IVS and IVT for its intended-purpose, characteristic and technology dimensions.
These are designation codes, not device risk classes. Check the applicable product category alongside characteristics, processes and notification limitations. A matching product code alone does not settle whether the body can assess your device.
Compare legal entities rather than corporate brands. A group's name may be familiar, but the NANDO notification defines the authorised entity and scope. Legacy-device transition or surveillance arrangements do not, by themselves, establish current MDR or IVDR designation.
Confirm capacity and submission requirements
Active designation does not guarantee an application slot. MDR Annex VII, section 4.3 includes checks on whether sufficient appropriate resources are available. Ask the body directly about intake availability before making a formal application.
For preliminary discussions, a practical enquiry should ask for:
- Written confirmation that the published scope covers your proposed device and route.
- Current intake availability and an indicative review and audit schedule.
- Submission requirements and accepted languages.
- An itemised quotation and its assumptions.
This is a selection checklist, not a statutory application form. Public application-procedure information, including accepted languages, is required under MDR Annex VII, section 4.2(a). Confirm the requirements that apply to your submission rather than assuming English is accepted.
Keep the consultancy boundary clear. A body may exchange technical information and give regulatory guidance, but restrictions apply to consultancy. It is not your readiness consultant, and preliminary discussions do not promise approval of your evidence. See MDR Annex VII, sections 1.2.3 and 1.2.9.
Compare the full certification cost
Notified bodies must publish standard-fee lists under MDR Article 50 and IVDR Article 46. The Commission's notified-body page links to those fee-list resources.
Use published fees as a starting point, then request a device-specific quotation. Compare the expected certification cycle rather than the application fee alone. Ask which audits, surveillance activities, technical-documentation assessments, additional review rounds and changes the quotation includes. A published standard-fee list does not establish a fixed final price.
Choose before lodging a formal application
Manufacturers may choose an appropriately designated body. MDR Article 53(1) and IVDR Article 49(1) do not require one in the manufacturer's home Member State.
But those provisions prohibit parallel applications to another body for the same conformity-assessment procedure. Preliminary enquiries to a shortlist are different from formal applications. Resolve scope, availability and commercial questions before applying. The same articles require disclosure of previous withdrawals or refusals, so withdrawal does not erase the assessment history.
What the CE number tells you
Where applicable, the CE marking is followed by the relevant notified body's identification number under MDR Article 20(5). NANDO displays four-digit identifiers. Preserve any leading zeros when recording or searching them.
The number identifies the body, not the device. It does not prove that the body's scope covers your product, and not every CE-marked device requires a notified-body number. Check the current notification rather than relying on the number alone.
EU notified bodies and UK approved bodies
A UK approved body and an EU notified body hold different statuses. The MHRA approved-body list describes UKCA scopes in Great Britain under UK MDR 2002. It does not establish EU designation.
For EU CE marking, check the EU-designated legal entity in NANDO, even where the corporate group also operates in the UK. The Commission's Blue Guide distinguishes former UK notified-body status and addresses Northern Ireland separately. Keep the intended market clear when requesting a quotation.
RegAffairs AI has a public answer on choosing a medical-device notified body. The live NANDO notification remains the source for checking a body's current designation and published scope.