Proposed EU medtech laws seek more predictable and efficient notified body oversight

A central objective of the proposed Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) revisions introduced by the European Commission last December is to make notified body certification more predictable, proportionate and affordable, particularly for small to medium-sized enterprises (SMEs).

The draft amendments focus on how manufacturers engage with notified bodies, how conformity assessment is structured across risk classes and how oversight and dispute resolution are organised. Together, the changes are designed to reduce bottlenecks, while maintaining the independence and rigour of third‑party assessment.

Challenges

The Commission's targeted evaluation found that weaknesses in how notified bodies are designated and supervised, how conformity assessments are carried out and what is expected in terms of clinical evidence are "closely interlinked". This combination has led to well‑documented capacity constraints, patchy oversight and inconsistent evidence expectations, making certification timelines harder to predict and practices more divergent across the EU and in some cases prompting devices to be withdrawn from the market.

​Stakeholder feedback to the Commission's call for evidence echoed these concerns, pointing in particular to the lack of clarity on expectations before submission, the variability of questions raised during assessment, and the high costs of multiple review cycles. These findings are in line with the issues formerly described in the European Parliament's resolution of 23 October 2024. SMEs, in particular, underlined the difficulty of accessing notified body services on reasonable terms and called for greater transparency on fees and prioritisation mechanisms.

Structured dialogue

To respond to those concerns, the proposal suggests to formalise the dialogue between manufacturers and notified bodies as part of conformity assessment. The concept is not labelled in a single article but it is reflected in several amendments to annex VII (requirements to be met by notified bodies) of the two regulations and a number of related provisions.

Amended annex VII requires notified bodies to plan their assessment activities based on an assessment programme that takes into account the scope of the manufacturer's application, its risk class and the "state of the art" status.  

The Commission's explanatory memorandum further clarifies that notified bodies will be required to distinguish between changes regarding either the quality management system or the approved device or diagnostic, that manufacturers can implement:

• Without prior notification
• Without prior approval
• Only after approval by the notified body.

Where appropriate, the notified body and the manufacturer will have to agree on a predetermined change control plan.

This codifies a more structured, predictable approach to both pre‑submission interaction and change management. Manufacturers are expected to be able to discuss their intended conformity assessment strategy and planned post‑certification changes with their notified bodies, and to obtain upfront clarity on which changes will require prior assessment, which can proceed without prior notification, and which can be handled under an agreed change control framework.

Streamlined conformity assessment for certain products

A core simplification in the proposal concerns how technical documentation is sampled and assessed for medium‑risk devices.

Under the current MDR, article 52 (conformity assessment procedures) requires notified bodies to perform full technical documentation assessments for many devices. This contributes to heavy workloads. The proposal amends this provision to focus assessments on representative devices. For class IIb devices, the amended MDR provides that conformity assessment under annex IX (conformity assessment based on a quality management system and on assessment of technical documentation) should include an assessment of the technical documentation of one representative device per generic device group. For non-implantable class IIb devices that qualify as well‑established technology devices, the requirement is further relaxed to one representative device per category of devices. Similarly, for class IIa devices, the draft text allows conformity assessment under annex IX to apply with technical documentation assessment of one representative device for each category of devices.

For IVDs, the proposal takes a similar approach. Under amended article 48 (conformity assessment procedures) of the IVDR, class C and class B devices would follow annex IX with technical documentation assessment limited to representative devices. Class B devices would also gain an alternative pathway, combining the regulation's annex X (conformity assessment based on type-examination) and annex XI (conformity assessment based on production quality assurance). To ensure consistency, the Commission may adopt implementing acts under a new article 48 paragraph specifying how representative devices should be selected for class B and C diagnostics.

These provisions allow notified bodies to concentrate in‑depth assessment on carefully chosen exemplars within a product family, with the expectation that manufacturers maintain consistent design and manufacturing controls across that family. The Commission may adopt implementing acts specifying criteria for representative device selection, such as worst‑case configurations or highest‑risk indications, per the amended regulations.

Reduced sampling and extended surveillance intervals

In addition to pre-marketing simplifications, the proposal revisits surveillance practices. Annex IX to the regulations currently envisages periodic on‑site audits and sampling of devices, with stakeholders reporting that some annex IX practices – such as systematic annual sampling of technical documentation across portfolios – created workload without obvious safety gains.

The draft regulations shift the emphasis towards risk‑based surveillance and move away from systematic sampling requirements. Under the proposed framework, the Commission would be able to adopt implementing acts setting out how notified bodies should conduct unannounced on‑site audits and sample tests, with the approach tailored to the risk class and type of device concerned. The explanatory memorandum reinforces this direction, indicating that sampling intensity should reflect the actual risk profile of devices and relevant post‑market signals, rather than following a one‑size‑fits‑all approach across product portfolios.

The proposal also envisages the possibility of extending surveillance audit intervals in justified cases, although this is not spelt out as a fixed new interval in the core articles. 

Remote and on‑site audits

Operational experience during the COVID‑19 pandemic demonstrated the feasibility of remote and hybrid audits. While the MDR and IVDR already allowed some flexibility, the proposal consolidates this by empowering the Commission to define, through implementing acts, the modalities of unannounced on‑site audits and sample tests – and by implication – when remote techniques may be appropriate.

The amended annex IX retains on‑site audits where necessary, but the proposal's explicit reference to device risk and type provides a basis for formalising remote or desk‑based surveillance in lower‑risk contexts. It is hoped that this approach would reduce travel and scheduling burdens, particularly for SMEs and manufacturers operating across multiple smaller sites.

Reduced fees and enhanced access 

The proposal directly addresses the cost of conformity assessment, particularly for smaller entities, through a new article 50 (access to notified bodies and fees) of the MDR and a parallel provision in the IVDR. The changes are two-fold.

Under article 50 (1) of the MDR, notified bodies would be required to establish and publicly disclose lists of their fees for conformity assessment activities, and to notify these to the Commission for publication on a dedicated website.

Article 50 (2) of the MDR introduces mandatory fee reductions for smaller manufacturers. Notified bodies should apply at least a 50% fee reduction for micro-enterprises and at least a 25% reduction for SMEs. A 50% reduction is also required for manufacturers seeking conformity assessment of an orphan device. In addition, notified bodies should offer micro-enterprises and SMEs the option to defer fee payment until the relevant conformity assessment activity has been completed.

The Commission may adopt implementing acts specifying the structure and level of fees, taking into account the need to ensure high standards of device safety, availability of devices, support for SMEs and innovation.

Designation, monitoring and reassessment of notified bodies

To underpin these improvements, the proposal significantly revises the rules on designation and monitoring of notified bodies across both regulations.

First, the obligation to carry out a full reassessment of notified bodies every five years is removed. Instead, the draft requires authorities responsible for notified bodies to assess each notified body "at least once a year" and, where necessary, to include on‑site audits. New provisions mandate that at least every two years, this annual assessment should be carried out by a "joint assessment team" that includes the national authority and two experts appointed by the Commission in consultation with the medical device coordination group (MDCG).

Joint assessments would eventually culminate in a final monitoring report, which should be submitted to the MDCG and may contain recommendations regarding the notified body's designation. Where non‑compliances are identified, the body should submit a corrective and preventive action plan, which the authority or joint assessment team should consider and green light.

Second, the amendments propose that changes to the scope of a notified body's designation follow a streamlined process. This means that significant scope extensions would still trigger the full joint assessment process under the regulations, but other changes would be handled via a mere notification to the Commission and publication in NANDO, without automatic on‑site assessment.

Third, the two regulations are amended to give the Commission, in consultation with the MDCG, the power to initiate joint assessments where there are reasonable concerns about ongoing compliance of a notified body, or where national investigations are considered insufficient.

Finally, article 49 (involvement of notified bodies in conformity assessment procedures) of the MDR creates a formal "coordination group of notified bodies", replacing the previous, less formal coordination group structure. All notified bodies under the MDR and IVDR should actively participate, cooperate with each other, the Commission, national authorities, expert panels and laboratories, and adhere to a code of conduct approved by the MDCG. 

Disputes and resolutions

The proposal strengthens mechanisms for resolving disputes involving notified bodies. Proposed amendments to article 47 of the MDR and article 43 of the IVDR (challenge to the competence of notified bodies) would allow authorities responsible for notified bodies to impose conditions, suspend, restrict or withdraw designation where they fail to meet their obligations. The possibility for the Commission to trigger joint assessments in cases of concern gives manufacturers and other stakeholders an indirect escalation channel via the Commission or the MDCG.

Moreover, new draft classification dispute mechanisms  are intended to provide structured procedures where manufacturers and notified bodies disagree on classification, or where competent authorities challenge the classification of CE‑marked devices. The procedures involve consultation of other Member States, referral to expert panels  where there is disagreement, and adoption of reasoned decisions by competent authorities, with Commission implementing acts available to set further procedural details.

Osborne Clarke comment

The proposed changes go beyond incremental tweaks and amount to a re‑engineering of the notified body ecosystem, should they be adopted in their current or similar form following the EU legislative process. Structured dialogue and predetermined change control plans could help manufacturers and notified bodies to move away from reactive, issue‑driven interactions towards more planned, risk‑based assessment programmes. The focus on representative devices for class IIa/IIb and class B/C portfolios has the potential to be particularly impactful for manufacturers with broad product families, provided internal design control processes ensure that the representative truly reflects worst‑case characteristics.

As currently drafted, the combination of mandatory SME fee reductions, deferral of payments and explicit prioritisation for orphan devices would send a clear policy signal that the EU wishes to preserve innovation capacity among smaller players and niche manufacturers. At the same time, the more intensive, joint monitoring of notified bodies, the formal coordination group and the strengthened role of expert panels – including in classification disputes – are designed to drive greater harmonisation and accountability.

Together, the draft provisions would create a more formal architecture for addressing disagreements and offer the advantage of providing clearer expectations on timelines and escalation routes. At the same time, it remains possible that joint assessment findings and MDCG guidance could lead notified bodies to revisit existing practices, potentially tightening expectations in some areas. The final shape of these provisions will depend on the outcome of negotiations between the European Parliament and the Council, and stakeholders may wish to monitor the legislative process closely as it unfolds.