Skip to content
MOTION FOR A RESOLUTION (2024/2849(RSP))

On the urgent need to revise the Medical Devices Regulation

B-10-2024-0122

on behalf of the ESN Group · Rapporteur: Christine Anderson

Official HTML ↗ PDF DOCX
✦ In shortFull text
✦ In short · AI summary of this text, generated 4 Sept 2026

Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

The resolution calls for urgent revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, citing excessive bureaucracy, certification backlogs, and product shortages. It urges the Commission to speed up evaluation, present an amendment in the first half of 2025, and include measures like accelerated certification for innovative products and abolishing re-certification for lower-risk and niche products.

Key points

  1. Considers that both the IVDR and the MDR have created very burdensome bureaucracy, and suggests lifting any inappropriate or disproportionate regulatory burden as soon as possible.
  2. Recalls that in 2017 a Parliament minority moved to reject the new framework as too excessive a regulatory burden and too expensive for producers.
  3. Notes that proposals have been made to remedy problems through tertiary legislation, circumventing the ordinary legislative procedure, and warns against excessive use of delegated acts.
  4. Calls on the Commission not to use the full time frame for evaluation but to speed up the process, noting a call for a proposal within a hundred days of the new Commissioners' term.
  5. Calls on the Commission to present an amendment addressing shortcomings in the first half of 2025 and to conduct evaluation and present a full legislative proposal swiftly.
  6. Suggests including an accelerated certification procedure for innovative medical products, abolishing re-certification for lower-risk products, and abolishing certification for niche products.
  7. Considers that a strong and functioning civil liability regime already protects consumers, allowing certain regulatory requirements to be relaxed.

Who is affected

  • Producers of medical devices and in vitro medical devices, who face regulatory and administrative burdens.
  • Patients as consumers of medical products, who experience shortages and lack of innovation.
  • Healthcare authorities, who would benefit from immediate relief.

Figures and deadlines

  • 27 May 2027: deadline for the Commission to finalise evaluation of the regulations under Article 121 MDR and Article 111 IVDR.
  • First half of 2025: deadline for the Commission to present an amendment.