The European Commission has launched a public consultation to gather contributions on European regulations 2017/745 (medical devices) and 2017/746 (in vitro diagnostic medical devices). This process aims to assess the effectiveness of the rules currently in place and identify possible areas for improvement.
Objectives of the Regulations
The main objective of the regulations on medical devices and in vitro diagnostics is to ensure that only safe and effective devices are made available on the market.
In this way, the Commission aims to protect public health and patient safety, while promoting the competitiveness of the sector and supporting technological innovation.
Purpose of the Public Consultation
Participants can help identify gaps in the current rules and suggest improvements to ensure that the regulations are achieving their objectives effectively.
This process also aims to assess the administrative costs and benefits for patients and healthcare professionals.
Evaluation of the Efficiency and Impact of the Rules
The evaluation taking place in this consultation will help the European Commission to take stock of the existing rules, analyzing their effectiveness and impact on the sector.
It will evaluate, among other things, the effects of these rules on the supply of medical devices, including so-called “orphan devices”, and on encouraging the development of new innovative devices.
How to participate?
Interested parties can submit their contributions until March 21, 2025.
Comments and contributions can be submitted via the online platform available on the European Commission’s website.
For more information about medical devices, ELS can help.
Please contact your local ELS consultant or email: info@elssolutions.pt