The groups includes devices such as cosmetic contact lenses, tattoo removal lasers, equipment for liposuction, and others.

The MDR in § 15 introduces the role of the "person responsible for regulatory compliance" (PRRC), that manufacturers and authorized representatives will have to have available within their organisation.

The database will allow to link manufacturer's certification and Single Registration Number (SRN) as well as the Basic UDI.

The so-called "Summary of Safety and Clinical Performance" (SSCP), required for some high-risk medical devices, will also be accessible to the public through the database.

A medical device (including system- and procedure packs and IVD) needs to have an assigned Basic UDI-DI and needs to be registered in the UDI/Device part of EUDAMED.

The MDCG and its sub-groups publish guidances that provide clarification and support to national competent authorities, notified bodies and economic operators on the details of the implementation of the MDR and IVDR.

The company had received a CE certificate by Notified Body TÜV Rheinland but used un-certified silicone for the products.

This incident created significant public concern over the adequacy of the regulatory framework in ensuring medical device safety.

[8][9] The revision of European medical device regulations through by the repeal of the MDD and introduction of the MDR aimed to address existing gaps, improve Notified Body oversight, market surveillance, and enhance patient safety.

[11] A requirement for manufacturers on notifying authorities digitally about (potential) medical device supply chain disruptions was added to the regulation in 2024 (§10a).