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DRAFT REPORT (COM(2025)1023 – C10-0360/2025 – 2025/0404(COD))

On the proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

SANT-PR-787987

Committee on Public Health · Rapporteur: Oliver Schenk

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The draft report is the rapporteur's first version of Parliament's position on a proposal to simplify the rules on medical devices and in vitro diagnostic medical devices. It keeps patient safety safeguards while reducing administrative burden, clarifying regulatory status and classification, and adapting rules for breakthrough, orphan and niche devices. It amends Regulation (EU) 2017/745 and Regulation (EU) 2017/746 on single-use devices, equivalence, combined studies, notified body timelines, expert panels, advertising, importer checks and electronic instructions for use. It also amends Regulation (EU) 2022/123 on the European Medicines Agency's support for expert panels and Regulation (EU) 2024/1689 on the list of Union harmonisation legislation in its Annex I.

Committee position. The rapporteur proposes to amend the Commission proposal to simplify the rules while preserving patient safety safeguards, clarifying regulatory status and classification, supporting breakthrough, orphan and niche devices, and making conformity assessment and notified body procedures more efficient and predictable.

Key points

  1. Simplification must safeguard a high level of patient protection and confidence in the safety and performance of devices, and must not weaken clinical evidence requirements.
  2. Software updates that do not alter intended purpose, clinical functionality or risk profile should not trigger a new full conformity assessment; healthcare professionals keep professional judgement.
  3. Decisions on a product's regulatory status stay with the competent authority of the member state where the manufacturer is registered, or with the Commission through implementing acts.
  4. The coordination mechanism should not act as a parallel post-certification review of CE-marked devices, and should be used for them only where substantiated evidence shows an unacceptable risk.
  5. Requirements for devices used in medicinal product trials, especially in vitro diagnostics, should be proportionate to their role, with guidance for cases where no suitable CE-marked device is available.
  6. Information for lay users may be accepted in other commonly understood Union languages, and where a device is for professional users only, information should be provided in English.
  7. The manufacturer decides whether a device is single-use or reprocessable, with justification in the technical documentation; devices not indicated as single-use may be reprocessed, and fully refurbished devices are treated as new.
  8. New definitions cover niche devices, breakthrough devices and orphan devices (affecting not more than 12,000 individuals in the Union per year), with prioritised assessment and expert panel advice.
  9. The removal of the equivalence contract requirement is reversed, so equivalence claims, especially for high-risk implants, need robust product-specific clinical evidence.
  10. Sponsors may submit a single application for combined studies, with coordinated assessment under Regulation (EU) No 536/2014 and no parallel application of the device regulations.
  11. Notified body designation and monitoring get fixed timelines, and full joint assessment team involvement is required every five years instead of every two, with more frequent involvement where justified.
  12. Member states may not require prior authorisation for device advertising but may act against non-compliant advertising after publication; importers may verify compliance through documentation and risk-based sampling.

Who is affected

  • Manufacturers of medical devices and in vitro diagnostics: new rules on single-use designation, equivalence, quality audits and post-market reports.
  • Notified bodies: fixed assessment timelines, risk-based surveillance and recognition of previous assessments.
  • Health institutions and laboratories: in-house exemption conditions, including accreditation to EN ISO 15189.
  • Importers and distributors: notification duties before relabelling or repackaging and risk-based verification of compliance.
  • Patients and professional users: safeguards on clinical evidence, implant information and language of instructions.

Figures and deadlines

  • Expert panel opinion on well-established technology within 30 days of a substantiated request.
  • Expert panel opinion on regulatory status within 30 days of a complete request.
  • Orphan devices: disease or condition affecting not more than 12,000 individuals in the Union per year.
  • On-site assessment of a conformity assessment body within 90 days.
  • Final assessment report to the MDCG within 15 days; draft designation decision within 15 days.
  • Commission evaluation of a draft designation within 120 days of receipt of the referral.
  • Annual assessment of a notified body by a joint assessment team at least every five years.
  • National derogation authorising a device without conformity assessment for a period not exceeding 24 months.

Legal basis: Article 294(2) and Articles 168(4) and 114 of the Treaty on the Functioning of the European Union.