EU information and factsheet for manufacturers

Hospital scene with medical equipment in the foreground and two healthcare workers in blue scrubs attending to a patient in the background.

Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

The EU has a competitive and innovative medical devices sector, characterised by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users.

There are over 500 000 types of medical devices and IVDs on the EU market. Examples of medical devices are sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. IVDs are used to perform tests on samples, and examples include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.

The medical devices sector is essential to the provision of healthcare to citizens and is an important player in both the European and global economy.

Legislation

The European regulatory framework aims to ensure the safety and performance of medical devices and IVDs while facilitating patient access to devices on the European market.

The current EU framework is primarily based on two Regulations:

These Regulations introduced a more harmonised and robust regulatory system across all EU Member States. They replaced the previous Directives, which had allowed for differences in national implementation:

Unlike the former Directives, the MDR and IVDR apply directly in all Member States and place stronger emphasis on clinical evidence, transparency, traceability, and ongoing oversight throughout the product lifecycle.

The MDR has applied since 26 May 2021 and the IVDR since 26 May 2022. To allow manufacturers and notified bodies time to adapt to the new requirements, transitional provisions remain in place for certain legacy devices, provided specific conditions are met.

For medical devices, these transitional periods can extend until 31 December 2027 or 31 December 2028, depending on the device class and regulatory pathway. For IVDs, transition periods may extend until 31 December 2027, 31 December 2028, or 31 December 2029, depending on the risk class and compliance conditions. During these periods, manufacturers must progressively transition their devices to full compliance with the MDR or IVDR.