MDR/IVDR Reform Faces 130-Plus Amendments

A July draft report proposes more than 130 changes to EU medical device reforms, with a plenary vote expected around the new year.

10 Sep 2026

The European Parliament is shaping a major overhaul of EU medical device rules. On 1 July 2026, the SANT Committee rapporteur published a draft report containing over 130 proposed amendments to the Commission's MDR/IVDR simplification package.

Rapporteur Oliver Schenk of the EPP group from Germany launched Parliament's formal work on the targeted revision on 14 July. Political groupings faced a 20 July 2026 deadline to table their own proposed amendments to his draft.

Published 16 December 2025 as COM(2025) 1023 final, the underlying Commission proposal aims to reduce administrative burden by approximately 30%. It also addresses notified body capacity constraints. The Commission estimates the changes could deliver combined annual cost savings exceeding 3.3 billion euros.

MEPs on the SANT Committee broadly supported making existing rules more practical. Many stressed that regulatory simplification must not come at the expense of patient safety or robust clinical evidence.

The German Social Insurance EU representation office said it particularly welcomes retention of product liability for manufacturers and authorised representatives, the restriction of extended equivalence provisions for high-risk devices, and stronger involvement of scientific Expert Panels.

The MDR and IVDR entered into force in 2021 and 2022 respectively, introducing stricter requirements on clinical evidence, post-market surveillance, and economic operator obligations. A separate Implementing Regulation, EU 2026/977, sets uniform requirements for conformity assessment and notified bodies under Annex VII.

Autumn 2026 will host technical meetings to discuss the tabled amendments. A plenary vote in Parliament to formally adopt its position on the MDR/IVDR revision is expected towards or shortly after the new year, according to Arnold and Porter's BioSlice Blog.