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May 13, 2021

EU MDR TIPS

TIP # 2: ADDRESSING THE EU MDR DATE OF APPLICATION INCONSISTENCY
Author: Isabel Osorio, President and Owner of MDR Consultants Inc.

Per provisions of the EU MDR Regulation 2017/745, on the date of application (May 26TH of 2021) of the
Regulation, manufacturers having legacy devices (those that have an active and valid CE certificate issued
by a notified body under 93/42/EEC), should comply with the MDR requirements related to post-market
surveillance, market surveillance, vigilance, registration of economic operators and registration of
devices. It fails to mention the requirement of compliance with UDI requirements which is needed for the
registration process of devices into Eudamed. Please reference Article 120(3).

Because of this inconsistency, the Medical Device Coordination Group created 2 Guidance Documents
MDCG 2019-4 and MDCG 2019-5. These guidance documents state that the registration of devices is due
18 months from the application of the MDR (May of 2021), as long as the EUDAMED system is fully
functional, or if it is not fully functional on that date, 24 months after there is an official notice that the
system (EUDAMED) is fully functional and this is made official by being published in the Official Journal of
the European Union.

However, these considerations are related only to the registration of devices under the new EU MDR and
to legacy devices. All other obligations (post-market surveillance, market surveillance, vigilance, and
registration of economic operators) are applicable on the date of application of the EU MDR (May 26TH of
2021). In addition, Guidance document MDCG 2019-5 contains a foot note clarifying that all class I devices,
that have no notified body involvement (do not have a CE certificate and therefore are self-declared),
should be fully EU MDR compliant on the date of the MDR application (May 26TH of 2021) and therefore, they should be registered by that date as EU MDR devices (provided the Eudamed is fully functional).

For more information, please reference the following:
– EU MDR Regulation 2017/745 Article 120:
https://eur-lex.europa.eu/eli/reg/2020/561/oj

– MDCG Guidance Documents:
Guidance – MDCG endorsed documents and other guidance
Guidance – MDCG endorsed documents and other guidance | Public Health (europa.eu)

– MDCG 2019-4, Timelines for Registration of Device Data Elements in EUDAMED

md_mdcg_2019_4_devices_registration_eudamed_en.pdf (europa.eu)

– MDCG 2019-5, Registration of Legacy Devices in EUDAMED

md_mdcg_2019_5_legacy_devices_registration_eudamed_en.pdf (europa.eu)

– EUDAMED:
EUDAMED database – EUDAMED (europa.eu)

MDR Consultants Inc.
11111 Biscayne Blvd. Apt. 300, Miami, Florida, 33181
(786) 306-0227
info@mdrconsultants.com | www.mdrconsultants.com

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