Medical Device Regulation. New Legislation Support and Guidance
MDD to MDR
Find out how these changes impact your product
The Medical Devices Regulation (MDR) (EU) 2017/745 and In-Vitro Diagnostic Devices (IVDR) Regulation (EU) 2017/746 came into force in May 2017 with staggered transitional periods. These new regulations enact sweeping changes in the European legal framework for medical devices, introducing new responsibilities for economic operators, notified bodies and national competent authorities. Following their transitional periods, the MDR was scheduled to fully apply from 26 May 2020, and the IVDR from 26 May 2022 (the Application dates); in March 2020, due to the COVID-19 pandemic, the EC announced its intention to push this date back by 12 months.
A manufacturer can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment under the new EU MDR/IVDR, if it fully complies with these, or the previous EU Directives 93/42/EEC (MDD), 98/79/EC (IVDD) and 90/385/EEC (AIMDD) during the transitional periods. Doing so declares that product meets the prescribed legal requirements for such, and can be sold throughout the EEA without restrictions. This applies to products made in other countries that are sold in the EEA.
Contact us to understand how your CE-marked product will be affected by these changes and what you need to do to fully comply with the Regulations.
After the MDR Application date, relevant MDD or AIMDD certificates will remain valid until their expiration. MDD or AIMDD certificates issued for devices after the MDR came into force (25 May 2017) remain valid for up to five years, or until 27 May 2024 latest (whichever is soonest). Those medical devices meeting these conditions can be placed on the EU market until expiration of their certificate and may continue to be available in the supply chain until 27 May 2025.
There are several factors to consider for manufacturers that decide to keep their MDD or AIMDD certificates after the application of the MDR:
Compliance with the MDD or AIMDD must be maintained;
Significant changes in the design/intended purpose of the devices must be avoided;
Full MDR compliance is required from the date of Application for several aspects of the new legislation (e.g. stringent post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices, etc.);
The MDR requires the notified body that has issued the MDD or AIMDD certificate is responsible for surveillance in respect of all the above requirements.
UK legislation to adopt EU principles
Once the MDR Application date passes, several requirements of the legislation automatically commence, regardless of a product’s CE certificate being issued under the MDD/AIMDD. The changes to the roles and responsibilities of the economic operators (e.g. Importer, Authorised Representative, Distributor, etc.), the more onerous technical and vigilance requirements, and so on. The UK Government was due to adopt the Medical Devices Regulation (EU) 2017/745 into law via the current version of the UK Medical Devices Regulations. With the announcement from the EC in March 2020 of the intention to delay the MDR Application Date by a year due the COVID-19 pandemic, the planned country-specific changes to mandatory roles and functions are still to be decided. For information on how your company can prepare for the implementation of these regulations, please contact us.