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)
About the Author:
Isabel Osorio is the president and founder of MDR Consulting Inc. a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures. This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at firstname.lastname@example.org.