Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments.
The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.
Medical devices legislation
The Medical Devices Regulation (Regulation (EU) 2017/745) applies since 26 May 2021, following a four-year transition period.
Manufacturers must comply with the Regulation when placing new medical devices on the market.
It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.
The In-Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) will apply from 26 May 2022, following a five-year transition period.
In the meantime, manufacturers can opt to place in-vitro diagnostic devices on the market under Directive 98/79/EC or under the new Regulation if they fully comply with it.
Question-and-answer guidance on the implementation of the new Regulations is available below.