On 1 July 2026, the Rapporteur in the European Parliament’s Committee on Public Health (SANT) published his draft report (the Draft Report) in response to the Commission’s proposal to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) (the Commission Proposal). The details of the Commission Proposal are discussed in our December 2025 BioSlice blog post. The Draft Report contains over 130 suggested amendments to the Commission Proposal, giving an indication of what amendments the Parliament may target in the legislative process for the MDR/IVDR revision. The Report is therefore informative reading for industry on what amendments may ultimately be made to the MDR and IVDR.
The Draft Report, and the discussion of it in the SANT Committee, highlights that the Parliament is broadly supportive of the Commission’s attempts to promote a more proportionate regulatory framework. However, the proposed amendments would provide further simplification in some areas, while reintroducing obligations for manufacturers in others.
We discuss some of the key amendments proposed in the Draft Report below.
Regulatory Status and Classification: Coordination mechanisms under the MDR and IVDR
The Draft Report proposes changes to the mechanisms included in the Commission Proposal for evaluating the regulatory status and classification of a product. These include:
- Where a competent authority investigates the regulatory status of a product placed on the market as a medical device, the Draft Report proposes that competent authorities must have “substantiated evidence” that the product falls outside the scope of the MDR before commencing action in relation to the product. This would set a higher bar for authorities seeking to reopen the regulatory status of the product.
- The Draft Report proposes incorporating provisions to empower the Commission, taking into account any expert panel opinion (where applicable), to determine whether a CE-marked product falls within the scope of the MDR and/or its classification. This would be done through implementing acts with EU-wide effect, thereby supporting consistency across EU Member States.
- For the new pre-market procedure proposed in the Commission Proposal, the Draft Report suggests changes to make this a more EU Member State competent authority-led procedure. Only the relevant competent authority would be able to make a request to an expert panel for an opinion on the regulatory status of a prospective device (as opposed to the Notified Body, the manufacturer or developer of a prospective device and the Commission under the Commission Proposal). Manufacturers/developers would therefore be reliant on the competent authority of their home EU Member State to make a referral to the expert panel. Neither they nor their Notified Body would have discretion to initiate this themselves. Further, the Commission’s powers to make an EU-wide determination on the regulatory status of a pre-market product would be removed.
- In contrast, the Draft Report expands the stakeholders that can request an expert panel opinion on the classification of a device where a competent authority performs an evaluation of a device already on the market and queries whether it has been correctly classified. If the classification of a product is unclear, Notified Bodies, manufacturers, developers and the Commission could make the request for an expert panel opinion. This is in contrast to the Commission Proposal, under which only the competent authority who carried out the post-market evaluation of the product could request the opinion.
“Niche” devices
The Draft Report proposes the introduction of a further special category of device – that of “niche” devices, which would be in addition to “breakthrough” and “orphan” devices as defined in the Commission Proposal. A “niche” device would be one intended for a specific clinical use, procedure or patient subgroup, and which is made available only in limited volumes due to the specific nature of its intended purpose, and for which no suitable alternative is available or the absence of the device would adversely affect patient care. The justification provided is that some devices essential to patient care would not qualify as orphan or breakthrough devices. Given that niche devices serve small patient groups or clinical uses, they risk disappearing from the market due to disproportionate regulatory burden.
Under the Draft Report’s proposals, “niche” devices would be made subject to the same adapted conformity assessment procedure as the Commission Proposal would apply to breakthrough and orphan devices. Further, “niche” devices would benefit from extended transition periods similar to orphan devices under the Commission Proposal. This would mean they could be placed on the market beyond the transition period deadlines for other devices, subject to certain conditions. The Draft Report proposes that, where appropriate, the validity of the initial certificate for a “niche” device would be 5 years, which can then be renewed where the manufacturer has complied with the Post-Market Clinical Follow-Up Requirements specified by the Notified Body as a condition of the initial certificate. The Draft Report proposes the same approach for orphan and breakthrough devices.
Alignment of review timelines with linked medicinal products
The Draft Report proposes a new provision so that the conformity assessment timelines for companion diagnostics and drug-device products are in alignment with the review of a corresponding medicinal product that is on an accelerated assessment or expedited regulatory pathway. The Notified Body must, where appropriate, prioritise the conformity assessment and conduct a rolling review.
Use of IVDs in clinical trials
A new recital is suggested in the Draft Report to state that the requirements applicable to IVDs used in clinical trials of medicinal products should be “proportionate” to their role in the trial. It provides that guidance should be developed to indicate where adapted requirements should be considered. This includes situations where no suitable CE-marked device is available, where a CE-marked device is used for a different but closely related disease, condition, population or clinical context, or where the trial concerns a rare disease or condition. Any adapted requirements would need to safeguard trial subject safety and data quality. Such guidance would be a welcome development for the pharmaceutical and diagnostic industries, though it is unclear to what extent this will have any effect in practice given it is contained in a recital.
Health institution exemption and laboratories under IVDR
Currently, the IVDR exempts devices manufactured and used within the same health institution from most obligations under the Regulation, with the exception of the general safety and performance requirements. This exemption applies provided that certain conditions laid down in Article 5.5 of the IVDR are met.
The Proposal contains a provision allowing EU-based centralised laboratories to benefit from this exemption when providing services in the context of clinical trials, where they might not otherwise meet the conditions of the health institution exemption. The Draft Report proposes expanding this further to allow laboratories outside the EU to also rely on this exemption in the context of clinical trials. This would mean sponsors could use laboratories based outside the EU for diagnostic testing using non-CE marked tests, provided that the conditions laid down in Article 5.5 of the IVDR are met.
Software Medical Device Classification
The Commission Proposal contains a proposed replacement of the classification rule on software medical devices, aimed at the lower classification of certain software medical devices. The Draft Report suggests further changes to this classification rule, arguably making them simpler to apply. However, similarly to the original Commission Proposal, the amendments do little to make it easier for medical device software to fall within Class I.
Other changes include:
- Structured dialogue and pre-submission consultation: the Commission Proposal proposed a legal basis for the conduct of structured dialogues between manufacturers and notified bodies. The Draft Report goes a step further, adding that these dialogues may include structured and interactive exchanges, including pre-submission consultations, throughout the conformity assessment procedure.
- Reintroduction of liability and financial coverage. The Commission Proposal would delete the existing provision in the MDR providing an express statement that persons injured by devices may claim under product liability laws, and that the manufacturer must have proportionate financial coverage to cover its potential liability. The Draft Report suggests reintroducing such liability and coverage provisions.
- English language information only for professional-use devices. For devices intended exclusively for professional use, the product information required under MDR could be provided in English only, rather than the local language of the EU Member State.
- Provisions regarding the single use and reprocessed devices. These include amendments to ensure the decision on whether a device is “single-use” remains with the manufacturer, as well as labelling obligations for reprocessors, including providing the reprocessor’s name and address and indicating that a device has been reprocessed.
Next steps
The Draft Report was discussed at the SANT Committee meeting on 14 July 2026. Members of the Committee expressed support for many of the changes, though there were calls both for further simplification, as well as for reintroduction of measures in favour of patient safety.
The deadline for the political groupings to table any proposed amendments to the Draft Report was 20 July 2026. Technical meetings to discuss the amendments are expected to take place in the Autumn, with a plenary vote in Parliament to take place towards or shortly after the New Year at which the Parliament would formally adopt its position on the MDR/IVDR revision.
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