Medical Device Notified Bodies: MDR and IVDR Guide
Medical device notified bodies are independent organisations designated by EU Member State authorities to assess conformity under the MDR and IVDR. Their certificates allow many manufacturers to apply CE marking. This guide lists MDR notified bodies and IVDR notified bodies, explains when you need one and shows how to choose. I3CGLOBAL’s regulatory consultants can support your submission.
What Are Medical Device Notified Bodies?
Notified bodies are conformity assessment bodies designated under EU law. Regulation (EU) 2017/745 (MDR) covers medical devices, and Regulation (EU) 2017/746 (IVDR) covers in vitro diagnostic devices. A body designated under one regulation is not automatically designated under the other.
Notified bodies are commercial organisations, and manufacturers pay for their services. They are not regulators like the FDA, and their main power is over certificates, which they can issue, restrict, suspend or withdraw. Competent authorities remain responsible for market surveillance.
A body notified by one Member State can work across the EU. However, it can assess only the device types and activities within its scope.
Key facts
Medical Device Notified Bodies at a glance
- MDR bodies
- 51 active on the EU database, 4 November 2026
- IVDR bodies
- 19 active on the EU database, 4 November 2026
- Official list
- Single Market Compliance Space (NANDO data)
- Choice
- Your choice of body, if designated for your device type
- Parallel applications
- Not allowed for the same conformity assessment procedure
- Certificates
- Valid for up to 5 years
- Surveillance
- At least every 12 months, plus unannounced audits at least every 5 years
Which MDR Notified Bodies and IVDR Notified Bodies Are Active?
We took these lists from the European Commission’s Single Market Compliance Space on 4 November 2026, using active notifications only. The official database changes over time, so check it before you apply. A body’s presence in these lists does not confirm it can assess your specific device.
MDR notified bodies under Regulation (EU) 2017/745 (51)
| NB number | Notified body | Country |
|---|---|---|
| 0044 | TÜV NORD CERT GmbH | Germany |
| 0050 | National Standards Authority of Ireland (NSAI) | Ireland |
| 0051 | IMQ Istituto Italiano del Marchio di Qualità S.p.A. | Italy |
| 0068 | MTIC InterCert S.r.l. | Italy |
| 0123 | TÜV SÜD Product Service GmbH | Germany |
| 0124 | DEKRA Certification GmbH | Germany |
| 0197 | TÜV Rheinland LGA Products GmbH | Germany |
| 0297 | DQS Medizinprodukte GmbH | Germany |
| 0318 | Centro Nacional de Certificacion de Productos Sanitarios | Spain |
| 0333 | AFNOR Certification | France |
| 0344 | DEKRA Certification B.V. | Netherlands |
| 0373 | Istituto Superiore di Sanità | Italy |
| 0425 | ICIM S.p.A. | Italy |
| 0426 | Italcert SRL | Italy |
| 0459 | GMED SAS | France |
| 0476 | Kiwa Cermet Italia S.p.A. | Italy |
| 0477 | Eurofins Product Testing Italy S.r.l. | Italy |
| 0482 | DNV MEDCERT GmbH | Germany |
| 0483 | mdc medical device certification GmbH | Germany |
| 0494 | SLG Prüf und Zertifizierungs GmbH | Germany |
| 0537 | Eurofins Electric & Electronics Finland Oy | Finland |
| 0546 | Certiquality S.r.l. | Italy |
| 0598 | SGS Fimko Oy | Finland |
| 0633 | Berlin Cert GmbH | Germany |
| 1011 | NEOEMKI LLC | Hungary |
| 1282 | Ente Certificazione Macchine SRL | Italy |
| 1304 | Slovenian Institute of Quality and Metrology (SIQ) | Slovenia |
| 1370 | Bureau Veritas Italia S.p.A. | Italy |
| 1383 | Cesky Metrologicky Institut | Czech Republic |
| 1434 | Polskie Centrum Badan i Certyfikacji S.A. | Poland |
| 1639 | SGS Belgium NV | Belgium |
| 1912 | Kiwa Assurance B.V. | Netherlands |
| 1936 | TUV Rheinland Italia SRL | Italy |
| 1984 | Kiwa Belgelendirme Hizmetleri A.Ş. | Türkiye |
| 2265 | 3EC International a.s. | Slovakia |
| 2274 | TUV NORD Polska Sp. z o.o. | Poland |
| 2292 | UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. | Türkiye |
| 2409 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Hungary |
| 2443 | TÜV SÜD Danmark | Denmark |
| 2460 | DNV Product Assurance AS | Norway |
| 2696 | UDEM Adriatic d.o.o. | Croatia |
| 2764 | Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi | Türkiye |
| 2797 | BSI Group The Netherlands B.V. | Netherlands |
| 2803 | HTCert (Health Technology Certification Ltd) | Cyprus |
| 2862 | Intertek Medical Notified Body AB | Sweden |
| 2962 | QMD Services GmbH | Austria |
| 2975 | SZUTEST Konformitätsbewertungsstelle GmbH | Germany |
| 3022 | Scarlet NB B.V. | Netherlands |
| 3033 | TÜV NORD Scandinavia Medical Notified Body AB | Sweden |
| 3121 | NOTICE, storitve ugotavljanja skladnosti, d.o.o. | Slovenia |
| 3132 | Malta Conformity Assessment Ltd. | Malta |
IVDR notified bodies under Regulation (EU) 2017/746 (19)
| NB number | Notified body | Country |
|---|---|---|
| 0050 | National Standards Authority of Ireland (NSAI) | Ireland |
| 0051 | IMQ Istituto Italiano del Marchio di Qualità S.p.A. | Italy |
| 0123 | TÜV SÜD Product Service GmbH | Germany |
| 0124 | DEKRA Certification GmbH | Germany |
| 0197 | TÜV Rheinland LGA Products GmbH | Germany |
| 0318 | Centro Nacional de Certificacion de Productos Sanitarios | Spain |
| 0344 | DEKRA Certification B.V. | Netherlands |
| 0373 | Istituto Superiore di Sanità | Italy |
| 0459 | GMED SAS | France |
| 0483 | mdc medical device certification GmbH | Germany |
| 0537 | Eurofins Electric & Electronics Finland Oy | Finland |
| 0598 | SGS Fimko Oy | Finland |
| 1434 | Polskie Centrum Badan i Certyfikacji S.A. | Poland |
| 1639 | SGS Belgium NV | Belgium |
| 2265 | 3EC International a.s. | Slovakia |
| 2460 | DNV Product Assurance AS | Norway |
| 2797 | BSI Group The Netherlands B.V. | Netherlands |
| 2962 | QMD Services GmbH | Austria |
| 3018 | Kiwa Sertio Oy | Finland |
How do you check a notified body’s scope?
- Open the official database, and filter by Regulation (EU) 2017/745 or 2017/746.
- Confirm the legal entity, country and four-digit notified body number.
- Match each relevant designation code to your device type and technologies.
- Confirm the body is designated for your conformity assessment route.
- Record the date you checked, and repeat the check before you apply.
Fewer IVDR notified bodies: the IVDR list is much shorter than the MDR list, so check scope and capacity early for class B, C and D devices.
When Do You Need Medical Device Notified Bodies?
The need depends on the device classification and conformity assessment route. Class I devices without special characteristics, and non-sterile class A IVDs, are self-declared by the manufacturer. Other classes involve a notified body to some degree.
| Regulation | Device class | Notified body involvement |
|---|---|---|
| MDR | Class I, not sterile, not measuring and not a reusable surgical instrument | Not required; the manufacturer self-declares |
| MDR | Class Is, Im and Ir | Limited to sterility, metrology or reuse aspects |
| MDR | Class IIa, IIb and III | Required; the depth of assessment increases with risk |
| IVDR | Class A, non-sterile | Not required; the manufacturer self-declares |
| IVDR | Class A sterile | Limited to sterility aspects |
| IVDR | Class B, C and D | Required; the depth of assessment increases with risk |
For a wider overview, see our guides to medical device CE marking and the EU IVDR. A notified body cannot rely on general product claims, so prepare the technical file and quality management system before you apply.
What Do Notified Bodies Do?
The main task of notified bodies is conformity assessment. Before starting, they verify that the device falls within their scope, and check the classification proposed by the manufacturer.
1
Audit the quality system
They assess and audit the quality management system, including relevant sites and, where applicable, critical suppliers.
2
Assess technical documentation
They review documentation, including GSPR evidence and clinical evaluation or performance evaluation.
3
Verify products
Depending on the route, they may review samples, carry out or request tests, or perform type examination.
4
Issue and maintain certificates
They issue certificates, and can restrict, suspend or withdraw them if requirements are no longer met.
What can notified bodies not do?
- They cannot be the designer, manufacturer, supplier or owner of a device they assess, or the authorised representative of any of those parties.
- Their staff must declare potential conflicts of interest, and financial interests must not affect a certification decision.
- They must keep client information confidential, except where disclosure to authorities is required.
- They cannot act outside their designated scope, and they must use properly qualified staff.
- They must not provide consultancy services to the manufacturer on the devices they assess. Manufacturers often use an independent consultant, such as EU MDR consultants, for preparation.
How Are IVDR and MDR Notified Bodies Designated?
A conformity assessment body applies to the responsible authority in its Member State. The HPRA explains that the requirements sit in Chapter IV and Annex VII of each regulation, and that the assessment involves experts from the European Commission and Member States.
After designation, the national authority monitors the notified body, including audits and reviews of its technical and clinical assessments. Under MDR Article 44 and IVDR Article 40, a complete re-assessment takes place three years after notification and every fourth year after that. It also involves a joint assessment team.
Notified bodies must also communicate with authorities about their assessments, certificates that are issued, changed, suspended or withdrawn, and significant organisational changes.
How Do You Choose Between Notified Bodies?
MDR Article 53 and IVDR Article 49 let you apply to the notified body of your choice if it is designated for your device type. You cannot lodge parallel applications with another body for the same conformity assessment procedure, so compare carefully first. These seven tips apply to medical device and IVD notified bodies.
- Confirm designationCheck the correct regulation, the designation codes and your conformity assessment route.
- Assess relevant experienceAsk about experience with similar devices, technologies and clinical or performance evidence.
- Ask about capacityFind out whether the body is accepting applications, and when reviewers and auditors can start.
- Compare full costsReview standard fees and quotations for audits, review, travel, surveillance, changes and recertification.
- Review communicationAsk how questions are handled, and how continuity is maintained during the project.
- Plan for your portfolioConsider current devices, product families, future changes and any IVD or MDR overlap.
- Consider language and locationThese matter for audits and documents, but usually come after scope, expertise and capacity.
Can you change your notified body?
Yes. MDR Article 58 and IVDR Article 53 cover voluntary changes, which require an agreement between the manufacturer, the incoming body and, where practicable, the outgoing body. Plan the transfer early to avoid a gap in coverage, and update certificates, labels and registrations where needed.
How Long Does Notified Body Certification Take?
Timing varies by device, documentation quality and capacity. The European Commission’s 20th notified bodies survey, with data to 28 February 2026, reports these periods from signed agreement to new certificate.
| Certificate type | Most common reported period | Next most common |
|---|---|---|
| MDR QMS | 13 to 18 months (62% of bodies) | 6 to 12 months (30%) |
| MDR QMS and product | 13 to 18 months (51%) | 19 to 24 months (31%) |
| IVDR QMS | 13 to 18 months (50%) | 6 to 12 months (42%) |
| IVDR QMS and product | 13 to 18 months (67%) | 6 to 12 months (25%) |
The same survey reports 31,902 MDR applications lodged (32,898 when counted by annex) and 18,010 MDR certificates. For the IVDR, it reports 3,723 applications lodged (3,418 by annex) and 2,318 certificates.
What changes from February 2027?
Commission Implementing Regulation (EU) 2026/977 entered into force on 24 May 2026. Its time limits apply to agreements signed after 25 February 2027: 30 days for application review and contract, 120 days for the initial QMS audit, 90 days for initial product verification and 20 days for decision and certification. Only a limited number of clock stops is allowed for each step. Emergo by UL gives a useful summary.
Quotations must include minimum information, and the body must tell the manufacturer in advance, with reasons, if costs will exceed the estimate by more than 10%.
What are the usual project steps?
- PrepareConfirm classification and route, and prepare the QMS and technical documentation.
- Shortlist and applyVerify scope, compare quotations and submit one application for the procedure.
- Sign the agreementAgree the scope, sites, devices, costs and planned activities.
- Complete assessmentSupport audits and documentation review, and resolve non-conformities.
- Receive certificatesComplete your declaration of conformity, CE marking and EUDAMED tasks.
- MaintainSupport surveillance audits, unannounced audits, change notifications and renewal.
How much do notified bodies charge?
MDR Article 50 and IVDR Article 46 require notified bodies to publish lists of standard fees. A final price also depends on your device, sites and scope, so request a written quotation. See our notified body fee guide and CE certification cost page.
Notified Bodies Support from I3CGLOBAL
I3CGLOBAL is a global regulatory consulting company for medical devices, IVDs, pharmaceuticals and life sciences. We are not a notified body and do not issue CE certificates. Our CE marking consultants help you prepare for the assessment by your chosen body.
| Service | What our consultants do |
|---|---|
| Route assessment | Confirm classification, conformity route and notified body needs. |
| Shortlisting | Check designation scope, and help you compare suitable bodies and quotations. |
| Documentation | Prepare MDR or IVDR technical documentation and supporting evidence. |
| QMS readiness | Support quality system preparation and audit readiness. |
| Submission support | Coordinate your application and notified body communication. |
| Question handling | Help respond to questions and non-conformities. |
| Maintenance | Support annual technical file maintenance, changes and surveillance. |
Preparing for a notified body?
Share your device class, target market and current documents, and get a tailored proposal.
Medical Device Notified Bodies: Frequently Asked Questions
What are medical device notified bodies?
They are independent conformity assessment bodies designated under the MDR or IVDR. They assess quality systems, technical documentation or products, and issue the certificates needed for many devices.
How many MDR notified bodies are there?
The European Commission database listed 51 active notifications under the MDR on 4 November 2026. The list changes, so check the official database before you apply.
How many IVDR notified bodies are there?
The database listed 19 active notifications under the IVDR on 4 November 2026. This is far fewer than under the MDR, so check capacity early.
Where is the official list of notified bodies?
Use the Single Market Compliance Space, the European Commission website that holds the NANDO notified body information. Filter by Regulation (EU) 2017/745 or 2017/746.
Does every medical device need a notified body?
No. Class I devices that are not sterile, measuring or reusable surgical instruments are self-declared. Other MDR classes involve a notified body, at least for their specific aspects.
Do all IVDs need a notified body?
No. Non-sterile class A IVDs are self-declared. Class A sterile devices involve a body for sterility aspects, and class B, C and D devices need notified body assessment.
Can I apply to two notified bodies at once?
Not for the same conformity assessment procedure. MDR Article 53 prohibits parallel applications, so do your comparison before you submit a formal application.
How long is a notified body certificate valid?
MDR certificates are valid for the period stated on them, up to five years. They can be extended after re-assessment, and they are subject to surveillance during that period.
How long does certification take?
The European Commission’s 2026 survey shows that many notified bodies most often report 13 to 18 months from signed agreement to a new certificate. Your project may be different.
What is the four-digit number next to the CE mark?
It is the identification number of the notified body involved in the conformity assessment. It does not appear on class I or class A devices that the manufacturer self-declares.
Are UK Approved Bodies the same as notified bodies?
No. UK Approved Bodies are designated by the MHRA for UKCA marking in Great Britain, where a UK Responsible Person is also needed for non-UK manufacturers. EU notified bodies assess devices for CE marking under the MDR and IVDR.
Do the 2026/977 time limits apply to my current contract?
Generally no. The limits for application review, audits and certification apply to agreements signed after 25 February 2027. Check with your notified body for your own case.
Is I3CGLOBAL a notified body?
No. I3CGLOBAL is a regulatory consulting company. We help manufacturers prepare and coordinate, and the notified body makes its own certification decision.
Official References and Related Guides
- Regulation (EU) 2017/745 (MDR), Articles 44, 50, 53, 56 and 58, and Annexes VII and IX
- Regulation (EU) 2017/746 (IVDR), Articles 40, 46, 49, 51 and 53
- Commission Implementing Regulation (EU) 2026/977 on notified body timelines and quotations
- European Commission: notified body list
- European Commission: notified bodies survey, 2026
- HPRA: notified body designation and oversight
- Medical Device CE Marking
- EU IVDR Regulation
- Medical Device Technical File
- Notified Body Fees
- SSCP Guide
- Systems and Procedure Packs
- IVDR Classification
- EU Authorised Representative
Updated 6 November 2026 | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Asha Johnson, Manager, I3CGLOBAL