The MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are the EU’s rulebooks for making sure medical devices — like hip replacements, pacemakers, and blood test kits — are safe and effective before they reach patients. Think of them as the EU version of food safety standards, but for medical devices, instruments and tests. They define what manufacturers must prove, and provide requirements for the organisations that confirm their work. These organisations are called Notified Bodies.

A Notified Body (NB) is an independent organisation officially approved by an EU Member State to act as a safety gatekeeper. Before a manufacturer can sell a medical device in the EU, a Notified Body must review the technical evidence and issue a certificate confirming the device meets legal regulatory requirements (EU MDR / EU IVDR) — similar to a safety inspector signing off an airplane before people can fly in it. NBs come in all shapes and sizes, some are SMEs, some are linked to the government of their Member State, some are semi-state and some are fully private businesses. Team-NB is the association that represents over 85% of all NBs.

The key objectives of the new proposals by the EU Commission might be summarized as follows:
Simplify and streamline the regulatory framework to reduce administrative burdens and costs without impairing patient safety.
Enhance predictability and efficiency of certification processes while maintaining high safety standards.
Reduce financial costs for SMEs to ensure their competitiveness
Ensure device availability, including for orphan disease applications and for new technologies, the so-called “breakthrough devices”

The revision includes a welcome move toward digital documentation, electronic labelling, and remote audit tools, which can cut down on unnecessary paperwork, and result in reduced administrative burden and costs. It also allows for earlier dialogue between manufacturers and regulators. And it brings in faster pathways for truly innovative or “orphan” devices that address unmet medical needs, an area that has been absent in the EU regulatory framework until now.

TEAM-NB supports the objectives of the proposal. However, its members are concerned that the new proposal moves away from the tried-and-true methods used in other industries. Specifically, the proposal reduces the use of independent product testing and scales back “unannounced” audits and technical reviews—tools that have proven effective at keeping manufacturers compliant. Additionally, while individual countries usually oversee the organizations that inspect these devices, this new plan gives the European Commission an unusually high level of control. In short, the proposal shifts away from practical, hands-on oversight in favour of a more centralized, administrative approach without defining how this will be done in a way to maintain the high levels of security and safety of the current system.

Notified Bodies warn that several proposed cuts — no unannounced audits, less frequent reviews of safety reports, reduced documentation checks — would drop oversight below the standards that existed under the old pre-MDR/IVDR rules. Less checking doesn’t automatically mean fewer problems; it can mean problems go undetected for longer, with real consequences for patients. This is especially important for devices termed ‘medium-risk’. Medium-risk devices deserve the same consideration as others, due to their volume and the importance they play for all patients. Under the current system, the Technical Documentation for medium-risk devices is to be reviewed proportionally, with only 5 to 15% of medium-risk device groups to be reviewed by NBs. Under the new proposal this is proposed to be dropped to a single device. It is important to note that these device groups often have over 100 devices in them.
Additionally, it should be noted that especially medium and large sized manufacturers will benefit from this reduction of TD sampling. SMEs often only have one or two separate Technical Documentations that are already reviewed during initial certification, so SMEs would not benefit from this reduction of sampling.
This is of particular concern for IVD devices, or for devices used for patient tests. Given that each device will test multiple patients, the issue can therefore be compounded.

(ref.: EU Commissions Explanatory Memorandum in the new MDR and IVDR proposals)
Looking for cost-saving opportunities for manufacturers is a good idea. It should be noted that these cost savings will apply to all manufacturers, and not only to EU-based companies. However, these cost savings should not come with an unacceptable reduction in safety oversight. The reduction of Notified Bodies involvement would not have a major impact on reducing costs for manufacturers: compliant manufacturers still have to perform the relevant verification and validations, including clinical evaluations of their devices and show written evidence that medical devices are safe and effective. The costs associated to these activities will not change with the new proposal and encompass the majority of design and regulatory affairs costs for a manufacturer. It is not possible to pinpoint a real average cost of regulatory compliance, as each company produces different MDs that come with different requirements. All figures in that sense are voluntarily misleading to distort the debate and drive discussions on costs to sideline safety.

No, according to the paper “the general conformity assessment measures are estimated to provide around €2.1 billion in savings per year”. This is a grossly inaccurate statement. Industry figures place NB costs at less than 10% of overall MDR/IVDR compliance costs, further emphasising the proposal’s disproportionate focus on NB fees and not addressing the real cost drivers for manufacturers.
The total combined revenue of all 50 Notified Bodies across the EU was approximately €475 million in 2024. It is not possible to save more than four times an industry’s total earnings from that same industry — the math simply doesn’t work. This suggests the Commission’s estimates are based on flawed assumptions about how the system actually operates, and that the calculation takes into account safety missions that manufacturers would have to carry out, regardless of whether they make use of Notified Bodies or internal control systems. We therefore strongly warn about misleading figures that bear no reality to the actual market or current market practices.

The current business model for Notified Bodies may become unsustainable. The new rules give the European Commission a much larger role in oversight, which will lead to significantly higher administrative fees through the biennial audits from the EU. On top of these rising costs, a specific legal change in the proposal the removal of Article 10(16) —removing the requirement for manufacturers to carry their own liability insurance—shifts more of the legal and financial risk onto the inspection agencies themselves. There are wider reaching implications for patient safety to be considered here as for example, manufacturers could go bankrupt without liability insurance, causing risks to the supply of devices patients depend on, without any recourse.

A fee reduction of up to 50% for SMEs and the imposition of mandatory deferred payment schedules would have a major impact on the Notified Bodies viability. The large majority of medical device and IVD manufacturers fall under the SME definition and are therefore the customers/users of conformity assessments carried out by Notified Bodies.
Another major concern for financial sustainability is the proposed, almost integral removal of all Notified Body surveillance activities. Implementing this proposal would make Notified Bodies unattractive for their stakeholders, but also for NB ability to hire and maintain skilled technicians, with the risk of eventually creating a bottle neck in the overall system for the remaining activities that NBs will take on. These reductions would apply to all SMEs, not simply those based within the EU.

Beyond the concern noted in A3, patient safety may be compromised under the new MDR/IVDR proposal, as manufacturers lacking evidence of device safety and effectiveness could go undetected. Notified Body oversight is significantly reduced; technical documentation is assessed only “for cause,” surveillance audits are less frequent, unannounced audits depend on specific concerns, and no independent review is required for safety reports or updates such as Summary of Safety Clinical Performance (SSCPs) and Periodic Safety Update Reports (PSURs).

Team-NB supports the reform in principle; however, in the absence of an impact assessment, Team-NB calls for changes to be evidence-based, realistic, and introduced at a pace the system can absorb. Specifically, NBs want to see any proposed reductions in oversight supported by solid data that justifies the change while demonstrating continued commitment to patient safety. The fee discount proposals should be removed, with proper consideration given instead to changes that genuinely support EU-based SMEs without compromising the principle that NB assessments must be driven by product risk, not company size. To begin with the infrastructure to support the regulation could be focused on with full EUDAMED functionality, and Common Specifications completed first and the publication of the devices which are defined as Well Established Technologies.
Overall – Patient driven, data focused changes

The EU Declaration of Conformity is a legal document where the manufacturer declares that a medical device complies with the requirements of MDR 2017/745 or IVDR 2017/746. This is required for all medical devices regardless of whether a notified body is involved in the conformity assessment.

The cost of achieving compliance to the MDR and IVDR is variable dependent on numerous factors including the novelty, complexity, risk level, notified body chosen, and the expertise involved with the device. Notified bodies are required to publish their fees, and these can usually be found on each organizations’ website.

Designated notified bodies are listed on the NANDO website. This can be filtered for each legislation to identify notified bodies designated under the MDR and notified bodies designated under the IVDR.

The following devices require conformity assessment by a notified body:

• Class I sterile/measuring medical devices
• Class A sterile in vitro diagnostic devices
• Class IIa medical devices
• Class B in vitro diagnostic devices
• Class IIb medical devices
• Class C in vitro diagnostic devices
• Class III medical devices
• Class D in vitro diagnostic devices

Many notified bodies have published guidance on technical documentation submissions. These guidance documents are usually located on their own websites. Additionally, Team NB regularly hosts training sessions on technical documentation preparation which includes information on what is expected and common pitfalls made by manufacturers.

The time taken to conduct conformity assessment is variable dependent on numerous factors including the novelty, complexity, risk level, and capacity of the notified body. Typically, it can take between 9 months to 24 months for conformity assessment to be completed, but in some cases may be longer.

Some notified bodies offer expedited services which can decrease the time taken to gain certification.

The MDR and IVDR have introduced higher scrutiny for medical devices and IVDs. The European Commission have published multiple resources discussing these changes in detail.

Harmonised standards are standards which can be used to demonstrate conformity to legislation. The full list of harmonised standards for the MDR can be found here, and the full list of harmonised standards for the IVDR can be found here. It is not mandatory for manufacturers to use harmonised standards, but use is encouraged.

Verification is confirmation of meeting specified requirements for a device (i.e. has the device been made correctly) whereas validation is confirmation of meeting a specific intended use or application (i.e. does the device do what it is meant to do).

Verification and validation are both important throughout the conformity assessment process to ensure a complete understanding of the device, in addition to demonstrating a robust quality management system.

The involvement of an EURL is mandatory under IVDR 2017/746 for Class D IVDs. EURLs verify the performance of Class D devices and compliance with common specifications, and performance batch testing of Class D devices.

Article 100 of IVDR 2017/746 provides more information on EURLs, including listing their tasks. Commission Implementing Regulation (EU) 2022/948 also provides the tasks and criteria for EURLs.

Under MDR 2017/745 and IVDR 2017/746, in-house devices are medical devices manufactured and used within a single healthcare institution. Article 5(5) of MDR 2017/745 and IVDR 2017/746 list the conditions to placing these products on the market. A notified body would not be involved in the conformity assessment.

However, these devices are required to be manufactured and used under an appropriate quality management system. Although not a requirement, a manufacturer could choose to undergo certification of ISO 13485 which would involve a notified body review.

Regulation (EU) 2023/607 amended the transition timeline for medical devices. MDCG 2021-25 (Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and

to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC) provides guidance on the requirements for medical devices throughout the transition periods.

Regulation (EU) 2024/1860 amended the transition timeline for IVDs. MDCG 2022-8 (Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 27 May 2022 in accordance with Directive 98/79/EC) provides guidance on the requirements for IVD devices throughout the transition periods.

IMDRF is a group of global medical device regulators who work together to accelerate international medical device regulatory harmonisation and convergence. The current members are Australia, Brazil, Canada, China, European Union, Japan, Russie, Singapore, South Korea, United Kingdom and United Stated of America.

More information can be found on the IMDRF website.

Under MDR 2017/745, contact lenses can be classified as Class IIa, Class IIb, or Class III medical devices depending on their intended use and duration of contact. The classification dictates the required conformity assessment procedures. Class IIa, IIb and III devices require notified body involvement for conformity assessment.

Contact lenses may also be regulated under Annex XVI of MDR 2017/745 where they do not have an intended medical purpose. These products also require notified body involvement for conformity assessment.

EMDN is a nomenclature system for use by manufacturers when registering their medical devices in the Eudamed database which allows allocation of a device description. MDCG has published guidance on EMDN:

• The EMDN – The nomenclature of use in EUDAMED
• MDCG 2021-12: FAQ on the European Medical Device Nomenclature (EMDN)
• MDCG 2024-2: Procedures for the updates of the EMDN

The MDCG provides guidance documents that help clarify the interpretation and application of MDR 2017/745 and IVDR 2017/746 regulations. These guidelines are intended to harmonize practices and ensure that stakeholders interpret and apply the regulatory requirements consistently across the EU.