Q&A: EU MDR and IVDR notified body processes and transition periods explained

Q: What are notified bodies and what is their role?

Notified bodies are conformity assessment bodies designated in accordance with Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and Regulation (EU) 2017/746 (in vitro diagnostic regulation, IVDR). Thus, their role is to conduct conformity assessments for medical devices and IVDs in accordance with the MDR and IVDR and to issue certificates which show that the certified device complies with the applicable regulatory requirements.  

Notified bodies are third-party bodies that need to be independent of the manufacturer of the device in relation to which they perform conformity assessment activities. Notified bodies also need to be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude notified bodies from carrying out conformity assessment activities for competing manufacturers.

Q: When are notified body assessments needed?

Before placing a medical device on the market in the EU, conformity assessment by a notified body is needed for all devices other than the devices in the lowest risk classes. Thus, only Class I medical devices and Class A IVD devices can be self-certified by the manufacturer by compiling the technical documentation and drawing up an EU Declaration of Conformity. However, Class I medical devices and Class A IVD devices placed on the market in sterile condition as well as Class I medical devices that have a measuring function or Class I reusable surgical instruments need a conformity assessment by a notified body before placing them on the market. However, the involvement of the notified body in those procedures is limited to:

1. the aspects relating to establishing, securing and maintaining sterile conditions in the case of devices placed on the market in sterile condition,
2. the aspects relating to the conformity of the devices with the metrological requirements in the case of devices with a measuring function, or
3. the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related instructions for use in the case of reusable surgical instruments.

Q: How are medical devices and IVDs classified?

In the EU, medical devices and IVDs are classified according to the MDR and IVDR that have introduced risk-based classification rules for the devices (MDR/IVDR Annex VIII). The MDR classification ranges from Class I (lowest risk) to Class III (highest risk), with the risk level determined by factors such as the intended purpose of the device and its duration of contact with the body. For IVDs, the categories range from Class A (lowest risk) to Class D (highest risk), with risk assessments considering factors such as the public health risk and the risk to the individual. Below are some examples of devices belonging to each risk class:

Q: What different types of notified body assessments are there?

For devices requiring a notified body conformity assessment before placing on the market, there are three different routes introduced in the MDR and IVDR that the manufacturer can choose from:

1. Annex IX: Conformity assessment based on a quality management system (QMS) and on assessment of technical documentation (TD),
2. Annex X: Conformity assessment based on type-examination, or
3. Annex XI: Conformity assessment based on production quality assurance/ product verification.

However, in most cases, conformity assessment based on the QMS and TD is recommended, thus, in this question, we will only go through the details of that route.

First, the manufacturer needs to establish, document and implement a QMS that complies with MDR Article 10(9)/IVDR Article 10(8) and draw up the TD in accordance with MDR/IVDR Annexes II and III. Then, the manufacturer needs to lodge an application for assessment of its QMS and technical documentation with one notified body. Before issuing the EU certificate, the notified body will assess the QMS and TD. This assessment includes an audit performed by the notified body. When there are no findings or all the findings have been addressed by the manufacturer and closed by the notified body, the notified body will issue an EU certificate.

The notified body will carry out appropriate audits and assessments to make sure that the manufacturer applies the approved QMS and the TD still conforms with the MDR/IVDR periodically, at least once every 12 months. Those audits and assessments include audits on the premises of the manufacturer and, if appropriate, of the manufacturer’s suppliers and/or subcontractors. Additionally, the notified body will randomly perform unannounced audits on the site of the manufacturer and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors at least once every five years.

The manufacturer needs to inform the notified body of any planned substantial changes to the certified QMS, or the devices covered by the certificate. The notified body shall assess the proposed changes, determine the need for additional audits and verify whether after those changes the QMS and devices still meet the requirements of the MDR/IVRD.

The notified body needs to re-certify the certified QMS and devices at least every five years.

Q: Which additional conformity assessment procedures exist for some devices?

For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product, the notified body needs to seek scientific opinion from an expert panel on the clinical evaluation assessment report of the notified body based on the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the medical indication or indications and the PMCF plan, and give due consideration to the views expressed in the scientific opinion of the expert panel.

For devices with an ancillary medicinal substance, including medicinal substances derived from human blood or human plasma, the notified body needs to seek a scientific opinion from one of the competent medicinal product authorities or from the EMA on the quality, safety and usefulness of the substance by analogy with the methods specified in Annex I to Directive 2001/83/EC. The scientific opinion of the medicinal products authority consulted, and any possible update of that opinion, needs to be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable.

For devices manufactured utilising derivatives of tissues or cells of human origin and for devices with ancillary tissues or cells of human origin, or their derivatives, the notified body shall seek a scientific opinion from a human tissues and cells competent authority on the aspects relating to the donation, procurement and testing of tissues or cells of human origin or their derivatives. The scientific opinion of the human tissues and cells competent authority, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion of the human tissues and cells competent authority when making its decision. The notified body shall not deliver the certificate if that scientific opinion is unfavourable.

In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising non-viable products derived from animal tissue, the notified body shall apply the relevant requirements laid down in Regulation (EU) No 722/2012.

For devices, or their products of metabolism, that are systemically absorbed by the human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from a medicinal product competent authority or from the EMA, on the compliance of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC. The scientific opinion of the medicinal products authority consulted, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision.

For companion diagnostics, the notified body shall seek a scientific opinion from a medicinal product competent authority or from the EMA regarding the suitability of the device in relation to the medicinal product concerned. The notified body shall give due consideration to the scientific opinion when making its decision.

Q: What are some of the common findings during notified body assessments?

• QMS does not include adequate processes for e.g., risk management, clinical/performance evaluation including post-market clinical follow-up/post-market performance follow-up, post-market surveillance, incident reporting, or CAPA management, or the processes do not conform with the requirements in the MDR/IVDR.
• The TD does not comply with the minimum content requirements described in MDR and IVDR Annexes II and III.
• Risk management has not been done according to MDR/IVDR Annex I, section 3.
• The benefit-risk analysis does not comply with MDR/IVDR Annex I, sections 1 and 8.
• The information supplied by the manufacturer, i.e., the labelling and instructions for use do not comply with MDR/IVDR Annex I, Chapter III.
• The clinical/performance evaluation plan does not include an identification of the general safety and performance requirements of MDR/IVDR Annex I that require support from relevant clinical data/scientific validity and analytical and clinical performance data or the conformity with these requirements have not been described adequately in the clinical/performance evaluation report.
• The state of the art has not been defined adequately, or the safety and performance of the device has not been compared to the state of the art.
• Literature searches do not address all relevant considerations or have not been documented adequately.
• Equivalence has not been demonstrated adequately in cases where the clinical/performance evaluation is based on data from an equivalent device.

Q: What to take into account when choosing a notified body?

1. When choosing a notified body, the most important aspect to take into account is that not all notified bodies are designated to assess all types of devices. Commission Implementing Regulation (EU) 2017/2185 lists the codes and corresponding types of devices based on which notified bodies are designated. Thus, when choosing a notified body, the first thing to check is that the notified body codes and the device type match, i.e., that the notified body has been designated to assess the specific type of device. Usually, when reviewing the application lodged by the manufacturer, the notified body will verify the assignment of codes provided by the manufacturer or will assign these codes to the devices themselves. This verification is carried out in order to ensure that the notified body is able to assess the application based on its designation, and that it has available resources to carry out the relevant conformity assessment activities. The notified bodies designated in accordance with the MDR and IVDR are listed in the NANDO ( New Approach Notified and Designated Organisations ) Information System along with the applicable codes representing the device types for which they are allowed to perform conformity assessments for.
2. Another thing to consider is the languages the notified body uses when conducting assessments. For most notified bodies, English is one of their working languages, but it is not mandatory for all notified bodies to accept English. Furthermore, if the manufacturer prefers to use their local language in the notified body conformity assessment processes, then a notified body that accepts their local language must be chosen.
3. The manufacturer should also consider the price for the notified body services before choosing for which notified body to apply to for conformity assessment as prices differ from one notified body to another although generally the pricing model is similar between notified bodies. The standard pricing information is usually found on the notified body’s website, and the EU Commission has published fees on notified bodies websites for MDR and IVDR related services. However, for detailed pricing information, the manufacturer should contact the notified body for which prices they are interested in.
4. According to the latest notified body survey results, it takes on average 13‒18 months to issue a new EU certificate according to the MDR or IVDR. However, the certification time depends not only on the availability of the notified body but also on how well the manufacturer has complied with the regulations in the first place. Still, as there are still a limited number of notified bodies, the assessment timelines can be long due to the number of applications and assessment each notified body must process. Thus, manufacturers need to be prepared for long processes and should find out the timelines from the notified body before launching the application.

Q: What are the current transition periods for legacy devices?

The MDR and IVDR include transitional provisions for devices already on the market under the directives (legacy devices) during which these devices can be continued to be placed on the market although the directives are not in force anymore. To be able to utilise the transition periods, certain conditions have to be met:

• the legacy devices continue to comply with the applicable directives,
• there are no significant changes in the design and intended purpose,
• the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health,
• the manufacturer has put in place an MDR/IVDR compliant QMS within the timelines,
• a formal application with a notified body has been lodged and the notified body and the manufacturer have signed a written agreement within the timelines

The timelines for the transition periods are described briefly in the below figures. For more details, please take a look at our previous blog: What to know about medical device and IVD class changes and transition periods?

MDR transition timeline

IVDR transition timeline

Q: How are the latest proposals for amending MDR/IVDR anticipated to affect notified body processes and transition periods?

On Tuesday 16 December, the European Commission published a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices – Public Health. However, the processing of this proposal may take as long as a couple of years and the implementation cannot be properly estimated yet. Still, manufacturers should follow how the processing of these proposals is ongoing to make sure they are ready when changes take place. The main points of the proposed changes affecting notified body processes and transition periods are summarised below:

Medfiles supports medical device and IVD manufacturers in MDR and IVDR compliance, including device classification, conformity assessment strategy, notified body interactions and transition planning. Our experts help ensure that certification processes and regulatory timelines are aligned with current and upcoming EU requirements.

Author: Emma Talvitie 
Regulatory Affairs Expert, Medical Devices and IVDs  

Emma Talvitie is a medical device and in vitro diagnostic (IVD) regulatory affairs professional with a Master of Science (Tech.) degree in biotechnology, who has over 4 years of professional experience in MD and IVD regulatory affairs. Emma has a strong background in IVD regulatory affairs and assay development. During her studies she focused on assay development, especially in molecular diagnostics and immunoassays. She started her career by updating the IVDD compliant technical documentation of an IVD analyser to be compliant with the IVDR. She has also been responsible for planning, executing, data analysis and reporting of IVD assay verification and validation studies and contributed to writing and reviewing IVDR and FDA 510(k) documentation for IVD assays.

Since April 2023, as a Regulatory Affairs Expert at Medfiles, Emma has worked in varying projects helping clients with regulatory issues and compiling technical documentation for multiple medical devices and IVDs. Emma is exited about contributing to the development of innovative, high-quality devices that meet both regulatory requirements and user needs.  

See also:

• EU IVDR: Compliance with technical documentation, notified body processes and transition periods
• What importers and distributors need to know about EU MD and IVD regulations – regulatory compliance, labelling and marketing materials
• How to gather clinical evidence for IVD performance evaluation under EU IVDR?