What Are Notified Bodies?
Notified Bodies are independent organizations authorized by governments to check whether certain products, including medical devices, meet regulatory requirements. These organizations assess conformity to rules like the EU Medical Device Regulation (MDR) and the UK Medical Devices Regulations (UK MDR 2002, as amended).
Notified Bodies conduct various assessments, such as:
Reviewing technical documentation.
Auditing quality management systems (QMS).
Testing products.
Issuing CE (EU) or UKCA (UK) conformity certificates.
Notified Bodies in the EU
Regulatory Framework
In the EU, medical devices must comply with Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic devices. These rules are stricter than the previous Directives, making the role of Notified Bodies more demanding.
Designation and Scope
EU Member States designate Notified Bodies, which are listed in the European Commission’s NANDO database. Each Notified Body has specific scopes, such as:
General medical devices (Class I, IIa, IIb, III).
In vitro diagnostic devices (IVDs).
Specialized areas like software or implantable devices.
Manufacturers must choose a Notified Body that matches their product’s classification.
Key Tips for Manufacturers
Plan Ahead: Notified Body capacity is limited, so engage early.
Focus on Clinical Evidence: High-risk devices require robust clinical data.
Prepare for Audits: Ongoing surveillance audits are part of compliance.
Notified Bodies in the UK
Regulatory Framework
Since Brexit, the UK follows its own regulations for medical devices under UK MDR 2002. The UKCA (UK Conformity Assessed) marking replaces the CE marking for devices in Great Britain (GB).
Approved Bodies
In the UK, “Notified Bodies” are now called “Approved Bodies.” These organizations are designated by the Medicines and Healthcare products Regulatory Agency (MHRA). Like in the EU, they conduct conformity assessments and issue UKCA certificates.
Key Tips for Manufacturers
Understand Transition Rules: CE marking is valid in the UK until June 30, 2028, for most devices, but transitioning to UKCA is crucial.
Follow Northern Ireland Rules: For Northern Ireland, devices must carry CE or UKNI markings, depending on the assessment.
Be Aware of Capacity Limits: The UK also has a limited number of Approved Bodies, so plan early.
How to Overcome Challenges
Working with Notified Bodies or Approved Bodies can be challenging. Common issues include:
Limited Availability: There are not enough designated bodies, leading to delays.
High Documentation Standards: Technical files must be thorough and precise.
Regulatory Updates: Staying informed about regulatory changes is critical.
How Patient Guard Can Help
At Patient Guard, we simplify the regulatory process for medical device and IVD manufacturers. Our services include:
EU Authorised Representative Services: We help ensure compliance with EU MDR and IVDR requirements.
UK Responsible Person Services: We assist with UK market access.
Technical File Review: Our experts prepare and review documentation for assessments.
QMS Support: We help implement and maintain ISO 13485-compliant quality systems.
With offices in the UK and Germany, and experience supporting over 500 manufacturers, Patient Guard is your trusted partner for regulatory success.
FAQs
Notified Bodies operate under EU regulations to provide CE marking, while Approved Bodies operate under UK regulations to provide UKCA marking. Both assess conformity but are designated by different authorities.
Choose a Notified Body that is designated for your device’s classification and technical scope. Check the European Commission’s NANDO database for EU Notified Bodies or the MHRA website for UK Approved Bodies.
Yes, a device can have both markings if it complies with both EU and UK regulations. You may need to work with both a Notified Body and an Approved Body.
If your Notified Body loses its designation, you must transfer to another designated body to maintain compliance. This process requires careful planning to avoid market disruptions.
EU Notified Bodies
| Notified Body Name | Country | Identification Number | MDR | IVDR |
|---|---|---|---|---|
| BSI Group The Netherlands B.V. | Netherlands | 2797 | Yes | Yes |
| DEKRA Certification GmbH | Germany | 0124 | Yes | Yes |
| DEKRA Certification B.V. | Netherlands | 0344 | Yes | Yes |
| DNV Product Assurance AS | Norway | 2460 | Yes | Yes |
| Eurofins Product Testing Italy S.r.l. | Italy | 0477 | Yes | Yes |
| GMED SAS | France | 0459 | Yes | Yes |
| IMQ S.p.A. | Italy | 0051 | Yes | Yes |
| Intertek Medical Notified Body AB | Sweden | 2862 | Yes | Yes |
| NSAI (National Standards Authority of Ireland) | Ireland | 0050 | Yes | Yes |
| SGS Fimko Oy | Finland | 0598 | Yes | Yes |
| TÜV Rheinland LGA Products GmbH | Germany | 0197 | Yes | Yes |
| TÜV SÜD Product Service GmbH | Germany | 0123 | Yes | Yes |
Correct as of 12th January 2025
UK Approved Bodies
| Approved Body Name | Identification Number | Contact Information | Designated Scope |
|---|---|---|---|
| BSI Assurance UK Ltd | 0086 |
Vishal Thakker Email: [email protected] Tel: 0845 080 9000 |
Medical Devices (designation expires on 31 December 2025) Active Implantable Medical Devices (designation expires on 31 December 2025) In-vitro Diagnostic Medical Devices |
| DEKRA Certification UK Ltd | 8505 |
Christopher Blue Email: [email protected] |
Medical Devices (designation expires on 1 September 2027) |
| LNE-GMED UK Limited | 8521 |
Teresa Perry Email: [email protected] |
Medical Devices (designation expires on 23 January 2029) Active Implantable Medical Devices (designation expires on 23 January 2029) In-vitro Diagnostic Medical Devices (designation expires on 23 January 2029) |
| Scarlet NB UK Ltd | 8536 |
James Dewar Email: [email protected] |
Medical Devices (designation expires on 25 January 2029) |
| SGS United Kingdom Ltd | 0120 |
Lynn Henderson Email: [email protected] Tel: +44 (0)121 541 4743 |
Medical Devices (designation expires on 16 March 2027) In-vitro Diagnostic Medical Devices |
| UL International (UK) Ltd | 0843 |
Paul Daysh Email: [email protected] Tel: 01483 302130 |
In-vitro Diagnostic Medical Devices Medical Devices (designation expires on 21 December 2028) |
| TÜV Rheinland UK Ltd | 2571 |
Justin Morgan Email: [email protected] Tel: +44 (0)121 796 9400 |
Medical Devices (designation expires on 11 August 2028) In-vitro Diagnostic Medical Devices |
| TÜV SÜD BABT Unlimited | 0168 |
Monisha Phillips Email: [email protected] Tel: +44 (0)1489 558100 |
Medical Devices (designation expires on 11 August 2028) Active Implantable Medical Devices (designation expires on 11 August 2028) |
| Intertek Medical Notified Body UK Ltd | 8532 |
Sharmila Gardner Email: [email protected] Tel: 01277 321234 |
Medical Devices (designation expires on 24 August 2028) |
Correct as of 12th January 2025
Summary
Notified Bodies and Approved Bodies play a critical role in bringing medical devices to market in the EU and UK. By understanding their requirements and preparing early, manufacturers can streamline the certification process. Partnering with Patient Guard ensures your compliance efforts are smooth and efficient.
Contact us today to learn how we can help you succeed in the regulatory landscape.
Resources
- Medical Device Design and Development
- ISO 14971 and the Risk Management of Medical Devices
- CE Marking Medical Devices
- Software as a Medical Device (SaMD)
- Is My Product a Medical Device?
- IEC 62366-1 Usability Engineering and its use in Medical Device Design and Development
- How to Structure a Medical Device Technical File
- ISO 14971 Risk Management Templates
