The role of notified bodies
Notified bodies (NBs) are independent organizations designated by European Union (EU) member states to assess the conformity of certain medical devices and in vitro diagnostic devices (IVDs) before they are placed on the market. Notified bodies play a crucial role in ensuring that devices meet the stringent safety, performance, and quality standards established by EU legislation. Notified bodies conduct conformity assessments, which include reviewing technical documentation, conducting audits, and performing product testing to verify compliance with applicable regulations. If the requirements are being fulfilled, the notified body will issue a certificate. After that the manufacturer is allowed to market the medical device.
Low-risk medical devices and IVDs do not require notified body approval for CE marking. This applies to most class I medical devices and class A IVDs. An exception to this are medical devices in class I which are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, and sterile class A IVDs.
The so-called Blue Guide contains guidance on the application of all aspects of the single market for products, including the role and organisation of notified bodies [1].
Re-certification under MDR and IVDR
The introduction of the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) have significantly changed the landscape for medical device and IVD certification. These regulations aim to enhance the safety and performance of medical devices and IVDs by imposing more rigorous requirements on manufacturers and notified bodies.
Under MDR and IVDR, existing medical devices and IVDs that were certified under the previous directives (MDD 93/42/EEC and IVDD 98/79/EC) had to undergo re-certification to meet the new requirements. This process involves comprehensive evaluations of clinical data, post-market surveillance plans, and quality management systems.
One of the critical issues impacting the transition to MDR and IVDR is the delay in re-certifying notified bodies themselves. This process has been slower than anticipated, resulting in:
- Reduced Number of Designated NBs: The slow pace of re-certification has led to a limited number of notified bodies being available to conduct assessments under MDR and IVDR.
- Increased Workload for Designated NBs: The few NBs that have achieved designation are facing overwhelming demand, leading to extended timelines for conformity assessments.
At the moment of writing this post, there are 49 notified bodies designated for the MDR and only 12 notified bodies designated for the IVDR. This illustrates the need for notified bodies.
The Commission strives to maintain an up-to-date list of bodies notified by EU countries and make the necessary information available to all interested parties. Lists of notified bodies are on the NANDO website (New Approach Notified and Designated Organisations).
The MDR and IVDR also introduce new classifications for devices, enforced major changes for the majority of the self-certified former CE class I medical devices, which are now assigned higher risk classes. A similar situation exists for in vitro diagnostic medical devices (IVD). Hence, more medical devices and IVD need formal approval from a notified body before being marketed [2], as shown for IVD in the figure below.

Bottlenecks and their impact
For a period of 3 years following the publication of the MDR, manufacturers could decide to certify their products either under the new MDR or under the old MDD. However, since May 2020, this is no longer possible. All medical devices now require new certification by a notified body (NB).
NBs can only certify for the MDR after they have been designated for it. However, it has been obvious since 2019 that there are not enough notified bodies to carry out the certification, considering the number of existing medical devices in relation to the number of notified bodies. The accreditation of notified bodies has been a slow process, resulting in a back-log of certifications, as shown in the graph below. Please note that up to February 2024, the gap between the trend lines for the number of certifications issued and the number of applications is still widening, indicating that the certification bottleneck has not been solved yet.

The lack of certified NBs is a bottleneck for the certification of new medical devices (and re-certification of existing devices that were originally certified under the old legislation), which means that:
- Some manufacturers have opted to withdraw certain products from the market rather than undergo the complex and costly re-certification process, reducing the overall availability of devices.
- New and innovative devices face delays in entering the market due to the prolonged certification timelines, potentially slowing the pace of medical advancements.
- Healthcare providers and patients may experience disruptions in the availability of critical medical devices and IVDs, impacting patient care and treatment outcomes.
This is not a trivial problem; many medical devices are vital parts of patient care, and a lack of them would endanger successful treatments and even lives.
The situation has led to the approval of the European Commission to extend the transition period for devices with a higher risk class (class III and Class IIb), until 2027, while the transition of lower risk class devices—of which there are many more on the market—has been extended until 2028. On April 25, 2024, the European Parliament voted to conditionally extend the IVDR transition period, based on device risk class, to December 2029 at the latest. This change has come into effect with the publication of regulation 2024/1860 amending the MDR and IVDR regulations on July 9, 2024.
In regulation 2024/1860 [3], the EU recognizes the shortage of notified bodies and the bottleneck this causes for timely CE marking of IVDs under the IVDR and conditionally extends the transition period for IVDs that were CE marked under the IVDD directive 98/79/EC.
EU Regulation 2024/1860 further contains provisions to prevent shortages of critical medical devices and IVDs on the market, allowing competent authorities and health institutions to take mitigating measures, and requiring a prior notice by manufacturers to anticipate interruption or discontinuation of supply of medical devices and IVDs.
Beyond the EU: Mutual Recognition Agreements
Mutual Recognition Agreements (MRAs) are treaties between the EU and non-EU countries that allow for the mutual acceptance of conformity assessment results. MRAs can streamline the certification process by recognizing the competence of notified bodies in the partner countries, thus facilitating market access.
BREXIT
Now that the UK has left the EU, it is no longer a Member State, and since there is no MRA in place at present, the UK is no longer able to appoint notified bodies. Certificates from UK based former notified bodies ceased to be valid on 1st January 2021 and any manufacturer relying on a certificate from a UK based notified body for their CE marking now needs to get their product re-certified. In practice, this is not as bad as it sounds since most UK notified bodies have made arrangements to transfer their certification clients to subsidiary organizations based in a Member State.
The UK has adopted the requirements of the CE marking directives and Regulations into UK law as the basis for the new UKCA mark. This includes the need for independent certification in the same way, and for the same products, as for the CE mark, but the UK legislation now refers to what used to be notified bodies as ‘Approved Bodies’. Every organization which had notified body status in the UK in 2020 was offered the chance to become an approved body, and most of them have done so. There is a list on the .gov.uk website.
The UK is now free to appoint bodies from outside its own territory if it wishes to, and so the list includes bodies from the USA, New Zealand and elsewhere.
In theory, any manufacturer who needs a notified body Certificate for CE marking and an Approved Body certificate for UKCA marking is going to have to undertake two separate procedures and get two pieces of paper at the end. However, the technical requirements for testing and assessment of products will (for the moment, at least) be identical for CE marking and for UKCA marking, so in practice it is expected that most Approved Bodies will be able to help their customers with a fast-track path to notified body certification. Similarly, some notified bodies will undoubtedly see it commercially worth offering their clients a one-stop-shop for the necessary certification for both CE marking and UKCA marking.
Switzerland
For medical devices, Switzerland follows what is specified for the European Union (EU) system of compliance assessment and certification, based on bilateral agreements.
The European CE label, which permits medical devices to be placed on the market within the EU and, based on unilateral recognition of the CE label, also in Switzerland.
Swissmedic’s focus in the area of medical devices is thus on effective market surveillance. In addition, the designation and monitoring of the so-called conformity assessment bodies and the drafting of requirements in the form of technical standards also fall within Swissmedic’s remit.
References and Reading
- European Commission. Comission Notice 2022/C 247/01: The ‘Blue Guide’ on the implementation of EU product rules 2022. Off J Eur Union. 2022;C247/1-151.
- van Drongelen A, de Bruijn A, Pennings J, van der Maaden T. The impact of the new European IVD-classification rules on the notified body involvement. Natl Inst Public Heal Environ. 2018;28.
- Journal O. REGULATION (EU) 2024/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or disc. Off J Eur Union. 2024;1–10.