Medical devices

CPME Rapporteur: Dr Katrín Fjeldsted (IS), Janne Aaltonen (FI), Rudolf Reibel (DE)
CPME Secretariat: Mr Diogo TEIXEIRA PEREIRA

Regulation EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) were adopted in 2017. The Regulations aim to ensure that only safe and effective devices are on the EU market, to protect patient safety and public health while supporting innovation. The Regulations aim to create a robust, transparent and sustainable legal framework, further aligned with international practices, which improves clinical safety and fair market access for manufacturers.

CPME is member of the European Commission Medical Device Coordination Group and also of its Working Group on New Technologies