Consultation of MDR/IVDR reform – Sailab gathers feedback submitted by 25th September

15.9.2025 Lausunnot

The European Commission has launched a new Call for Evidence consultation in the context of the ongoing targeted MDR/IVDR reform.

This is an additional opportunity for our sector to shape the future of the EU medical technology regulatory framework, therefore we strongly encourage you to participate.

Aim of the consultation

The consultation seeks to feed into a targeted revision of the MDR and IVDR, with the objective to “simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate, while preserving a high level of public health and patient safety and maintaining the overall structure of the current regulatory framework.”

Submission details

Timeline: The consultation is open now and will close on 6 October 2025 at midnight (Brussels time).
Format: Each contribution may include up to 4,000 characters in free text plus one attachment (supporting evidence, position paper, or case examples) not exceeding 5 MB.
Please note that the submitted information appears publicly on the consultation website. The name of the submitter can be opted to be anonymized, but the name of the company will always appear.

How you can contribute

We strongly encourage all members to submit their own perspectives directly through the consultation portal by the deadline, 6 October.

Alternatively, you can submit your perspectives using the below form. Sailab will gather all the comments submitted by the 25th September 2025, and provide this feedback via the consultation portal by the deadline.

To make your contribution impactful, we recommend structuring your input around the below listed goals included in the Call for Evidence, e.g. by listing your top 3 issues under each point sharing case examples, or making concrete suggestions to achieve the below goals.

The main goals the European Commission aims to achieve through this consultation are:

Reducing the administrative burden, including reporting obligations
Enhancing the predictability and cost-efficiency of the certification processes of notified bodies
Making conformity assessment requirements more proportionate, especially for low- and medium-risk devices and those serving special patient needs
Enabling further digitalisation
Streamlining procedures, including those on governance
Enabling the EU medical device sector to benefit from international cooperation (including reliance, where appropriate)
Better aligning the regulatory framework with other relevant legislation

You may also wish to highlight what is missing from the Call for Evidence, such as innovation, change notification processes etc., or other critical topics not explicitly covered.