Medical devices in dentistry – the new MDR regulation

The medical devices shall be registered in the new European Database for Medical Devices (EUDAMED).

With the new regulation, much of the information will be available to the public.

The new Medical Device Regulation (MDR 2017/745) came into full force May 26th 2021. It replaces the Medical Device Directive (MDD 93/42 / EEC) in European legislation.
Medical devices approved (CE-marked) in accordance with the old MDD-directive, can be marketed until May 26th 2025.

The focus of the MDR is on new requirements regarding updating of documentation, post-market surveillance, risk analysis and improved traceability. Traceability becomes a requirement for all medical devices in the EU/EEA.

The medical devices shall be registered in the new European Database for Medical Devices (EUDAMED). The registration is based on the Unique Device Identification (UDI) system, EUDAMED. This is still under development and will come into force in May 2022.

Until now, the database EUDAMED 2 has been restricted to communication between the Competent Authorities. Much of the information that is to be registered in the new EUDAMED database will be available to the public.

Transparency

The new Regulation (EU) 2017/745 on medical devices (the MDR) establishes a stronger legal system for medical devices. It prioritises transparency and patient access to information. With these goals in mind, the Regulation introduces a new requirement for implantable medical device manufacturers to provide an ‘Implant Card’ (IC), giving patients easy access to all relevant information concerning the device which they have had implanted.

The UDI-system will also be used for the new Implant Card. The following types of implants are, however, exempt from the obligation of an Implant Card: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

The medical authorities in the Nordic States have not yet reached an agreed standpoint as to whether screw implants in dentistry are to be exempt.

Reference
Nytt regelverk för medicintekniska produkter i tandvården
Örtengren U, Hensten A
Tandläkartidningen 2021; 113(10): 56-9

Further reading:

https://www.medical-device-regulation.eu/download-mdr/

https://ec.europa.eu/health/md_eudamed/overview_en

https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_budi_mdr_en.pdf

https://www.medical-device-regulation.eu/tag/mdr-article-18/

NIOM Newsletter November 2021

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