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The Medical Devices Regulation (Regulation (EU) 2017/745) applies from 26 May 2021, following a four-year transition period.

This means that manufacturers must comply with the Regulation when placing new medical devices on the market from 26 May 2021.

The Regulation repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.

MDR is bringing new concept an is harmonizing the EU market. The challenges for economic operators are high not only due to new requirements, but also due to limited availability of notified bodies. 

Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine.

Medical devices that are co-packaged or obtained separately must be CE marked in accordance with the medical device legislation.

Article 117 of the Medical Devices Regulation introduced a new requirement for medicines with an integral device.

From 26 May 2021, the marketing authorisation application should include a CE certificate for the device or, if it is not CE marked but would need to be certified if marketed separately, the applicant must include an opinion from a notified body on the conformity of the device. This requirement does not apply to Class I devices (non-sterile, non-measuring).