The European Commission has launched a public consultation to assess Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on medical devices and in vitro diagnostic medical devices. The aim of this initiative is to gather stakeholders' opinions on the effectiveness of the current regulations and to identify any shortcomings.
A public consultation is ongoing to assess Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on medical devices and in vitro diagnostic medical devices. The European Commission's aim is to gather stakeholders' opinions on the effectiveness of the current regulations and to identify any shortcomings.
The MDR and IVDR regulations aim to ensure that only safe and effective devices are available on the market, while supporting a competitive and innovative industry.
Aspects to be evaluated
The evaluation will cover several key aspects.
- Effectiveness of the regulations: checking whether the objectives, particularly in terms of patient safety and public health, are being achieved.
- Costs and administrative burdens: analyse the costs and administrative burdens, especially for SMEs.
- Benefits for patients and users: examine the benefits for patients and healthcare professionals.
- Availability of devices: examine the impact on device availability, including orphan devices.
- Development of innovative devices: consider the impact on the development of innovative devices.
- Consistency with other European Union legislation: Assess the compatibility of other European legislation, especially when related to the environment and digital technology.
Take part in the consultation
The consultation is open until 21 March 2025. For further information and to take part, please visit the European Commission website.
For further information
info.meddev@fagg-afmps.be