A notified body is a conformity assessment body, independent of the manufacturer and designated by a member state under Regulation (EU) 2017/745. For most risk classes it reviews the quality management system and the technical documentation and issues certificates, without which the manufacturer may not affix the CE marking.
Definition and role
A notified body is, under Article 2(42) of Regulation (EU) 2017/745 (MDR, the European Medical Device Regulation), a conformity assessment body that has been designated in accordance with this Regulation. Under point 41, a conformity assessment body is a body that performs third-party conformity assessment activities including calibration, testing, certification, and inspection.
The notified body does not replace the manufacturer's responsibility. The manufacturer must assess the conformity of its device itself before placing it on the market (Article 52(1)). For most risk classes, however, a notified body must be involved. On the basis of its assessment, it issues certificates. Where applicable, its identification number follows the CE marking (Article 20(5)).
When a notified body is involved
Whether and to what extent a notified body is involved depends on the risk class (Articles 51 and 52, classification under Annex VIII). The table summarizes the rules of Article 52.
| Class | Involvement of the notified body |
|---|---|
| III | Conformity assessment under Annex IX or, alternatively, Annex X (type-examination) together with Annex XI (product conformity verification). |
| IIb | Quality management system (Annex IX, Chapters I and III) and assessment of the technical documentation of at least one representative device per generic device group. For implantable class IIb devices, the assessment applies to every device as a rule, with a few named exceptions such as sutures or screws. |
| IIa | Quality management system and assessment of the technical documentation of at least one representative device per category of devices. Alternatively, the manufacturer can draw up the technical documentation and apply a procedure under Annex XI. |
| I | As a rule, a declaration by the manufacturer without a notified body. For sterile devices, devices with a measuring function, and reusable surgical instruments, involvement is limited to certain aspects. |
Annex XIII applies to custom-made devices. For implantable custom-made class III devices, a notified body is involved as well. For certain devices, an additional consultation procedure on the clinical evaluation applies, namely for implantable class III devices and for active class IIb devices intended to administer or remove a medicinal product (Article 54). The clinical evaluation itself is covered by the term Clinical Evaluation and PMCF.
Conformity assessment procedure and outcome
The manufacturer chooses the notified body itself, provided the body is designated for the type of device concerned. The manufacturer may not lodge an application in parallel with a second notified body for the same procedure and must disclose earlier withdrawn or rejected applications (Article 53(1) and (3)). The notified body may require all information and data it needs for the chosen procedure (Article 53(4)).
When assessing the technical documentation under Annex IX Section 4, the notified body uses personnel with demonstrated knowledge of the technology and its clinical use. It can require further tests or evidence. It verifies the manufacturer's conclusions on the general safety and performance requirements (GSPR). This includes the adequacy of the benefit-risk determination, risk management, instructions for use, user training, and the post-market surveillance plan (Section 4.6). If the outcome is positive, it issues an EU technical documentation assessment certificate. Changes to the approved device that could affect safety, performance, or the conditions of use require its approval (Section 4.10).
Certificates are valid for a maximum of five years and can each be extended by up to five years following a reassessment (Article 56(2)). The notified body can restrict, suspend, or withdraw certificates. It can also limit the intended purpose to certain groups of patients or require post-market clinical follow-up (PMCF) studies (Article 56(3) and (4)). It enters issued, suspended, and withdrawn certificates into an electronic system whose information is publicly accessible (Article 56(5)).
Designation, oversight, and coordination
Notified bodies are not selected by the manufacturer or by the European Commission but are designated by the member states. A member state may designate only bodies that have completed the assessment procedure under Article 39 and meet Annex VII (Article 42(1)). The designation is notified to the Commission and the other member states through the NANDO database and published there. It uses codes to define which activities and types of devices the body may assess. It takes effect on the day after publication (Article 42(2), (3), and (11)). The Commission assigns an identification number and keeps the public list of notified bodies up to date (Article 43).
After designation, the body is monitored continuously. The competent authority checks at least once a year, including an on-site audit, whether the requirements continue to be met. Five years after designation, and every five years thereafter, a full reassessment follows (Article 44). The Commission also ensures that a coordination group of notified bodies is set up, which meets at least once a year (Article 49). Notified bodies must keep a public list of their standard fees (Article 50).
Annex VII requires independence and impartiality. In particular, the notified body may not offer the manufacturer consulting on the design, construction, marketing, or maintenance of the devices to be assessed (Section 1.2). This is relevant for working with consultants: usability consulting and certification remain separate.
Human factors in conformity assessment
The MDR does not treat usability engineering as a procedure of its own. The requirements are set out in the general safety and performance requirements. Under Annex I, Chapter I, point 5, the manufacturer must reduce risks arising from use errors (use error). It must take into account the ergonomic features of the device and the environment of use, as well as the technical knowledge, experience, education, training, and medical and physical conditions of the intended users, including lay persons, professionals, and persons with disabilities.
The technical documentation must demonstrate these requirements. Annex II point 4 requires the justification, verification, and validation of the chosen solutions as well as the standards or other solutions applied. Point 5 requires the results of risk management (risk management). Point 6.1 expressly names simulated-use testing among the tests. The notified body sees these documents as part of its assessment. For class IIa and IIb devices, this happens on a sampling basis per device group or category.
To structure this evidence, manufacturers usually draw on the standard IEC 62366-1, with the results brought together in the usability engineering file. The standard is not harmonized under the MDR: Implementing Decision (EU) 2021/1182 on harmonized standards, in the version of June 17, 2026, does not list it (as of October 2026), whereas ISO 14971 and ISO 13485 are listed. There is therefore no presumption of conformity under Article 8 for the usability standard. The manufacturer must itself justify the choice of the standard and the effectiveness of the solution, and the standard remains applicable as the recognized state of the art. This is an inference from the legal text and not an explicit statement by an authority.
In practice, this means: The results of the summative evaluation and the risk analysis should refer traceably to the requirements of Annex I and Annex II. The manufacturer should clarify early and directly what additional expectations an individual notified body has. The body itself may not provide consulting, but it can state its requirements for the documentation.
Distinction from related terms
- The notified body assesses, while the manufacturer declares and marks. The outcome, the EU declaration of conformity and the CE marking, is covered by the term CE Marking and Technical Documentation.
- The registration and traceability of devices through the UDI is a separate set of obligations (UDI).
- Post-market surveillance is the manufacturer's responsibility but feeds into the oversight by the notified body (post-market surveillance).
- There is no notified body in the United States. There, the FDA decides itself, for example in the PMA process.
The notified body is an independent conformity assessment body designated by a member state under the MDR. For classes IIa, IIb, and III it is involved in the conformity assessment, for class I only in special cases. The manufacturer chooses it from the bodies designated for its type of device.
It reviews the quality management system and assesses the technical documentation, in part on a sampling basis. If the outcome is positive, it issues a certificate valid for a maximum of five years. Its identification number follows the CE marking.
For human factors, the requirements of Annex I point 5 and the evidence in Annex II count. The standard IEC 62366-1 is not harmonized under the MDR but serves as the state of the art for the usability engineering file.
Frequently asked questions (FAQ)
Who selects the notified body?
The manufacturer chooses it, provided it is designated for the type of device concerned. The list of notified bodies and the scope of their designations is publicly available in the NANDO database. A parallel application to a second body for the same procedure is not permitted.
Does every medical device need a notified body?
No. For class I devices, the manufacturer as a rule declares conformity itself. For class I, a notified body is required only for sterile devices, devices with a measuring function, and reusable surgical instruments, and then only for certain aspects. For classes IIa, IIb, and III, it is involved as a rule.
Does a notified body check the usability of the device?
It assesses the technical documentation, which contains the evidence for Annex I point 5, such as risk management, simulated-use testing, and instructions for use. The depth of the assessment depends on the risk class and the device. The body does not as a rule conduct a usability study of its own.
May a notified body advise on development?
No. Under Annex VII, it may not offer the manufacturer consulting on the design, construction, marketing, or maintenance of the devices to be assessed. It may, however, explain what requirements it places on the documentation.
Does the usability file have to be structured according to IEC 62366-1?
The standard is not harmonized under the MDR, so applying it does not establish a presumption of conformity. It is, however, regarded as the recognized state of the art. Anyone who deviates from it must justify the chosen solution and demonstrate that the requirements of Annex I are met.
Are you preparing a conformity assessment? We support you in structuring the usability evidence so that it is traceable in the technical documentation.
More about our usability engineeringSources
- Regulation (EU) 2017/745 on medical devices (MDR)
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971:2019, Medical devices, Application of risk management to medical devices
- ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purposes
- Regulation (EU) 2017/745 (MDR), consolidated version of 01/01/2026
- Commission Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices, consolidated version of 06/17/2026