14 March 2018 - Authored by:Eveline Van Keymeulen
In the first post of our “Getting ready for the MDR” series, we have a look at the key timelines that manufacturers need to be aware of as they prepare for the application of the EU Medical Devices Regulation (MDR).
Time is going by fast and the new MDR will soon become applicable. Its application date is set at 26 May 2020, following a three year transitional period from its entry into force on 25 May 2017.
However, the date of application of the MDR is subject to several derogations. We outline below the key timelines that manufacturers need to be aware of in order to prepare for the changes brought by the MDR to the current regulatory framework established by the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).
I. Before 26 May 2020
Early MDR application
Manufacturers will be able to seek certification of their medical devices under the MDR even before its date of application, i.e. 26 May 2020. This will be possible as soon as the first notified bodies having obtained MDR designation from the competent authorities will become available. In that respect, notified bodies have been able to apply for MDR designation since 25 November 2017, further to a Commission implementing regulation providing a list of codes for the designation of notified bodies under the MDR. According to the NBOG’s Best Practice Guide, it is expected that the first notified bodies will obtain MDR designation in July 2019, less than a year before the application of the MDR.
Assuming manufacturers will have obtained MDR certification of their devices in time, they will be able to place them on the market under the MDR provisions even before 26 May 2020.
II. After 26 May 2020
MDD and AIMDD certificates
After 26 May 2020, medical devices covered by a valid MDD or AIMDD certificate will still be able to be placed on the EU market until expiration of their certificate (and no later than 27 May 2022 in case of “Annex 4/IV” certificates granted prior to 25 May 2017). For devices which MDD or AIMDD certificates were issued after the entry into force of the MDR (25 May 2017), all certificates will last no more than five years and will become void on 27 May 2024 at the latest.
Devices with MDD or AIMDD certificates lawfully placed on the market may continue to be available in the supply chain until 27 May 2025.
Manufacturers deciding to keep their MDD or AIMDD certificates after the application of the MDR will have to consider the following:
- The devices must continue complying with the MDD or AIMDD;
- Manufacturers must avoid any significant changes in the design or the intended purpose of their devices; and
- They will need to comply with the MDR in relation to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.
Additionally, the MDR provides that the notified body that has issued the MDD or AIMDD certificate continues to be responsible for surveillance in respect of all the above requirements (which may become problematic if the notified body has ceased its activities).
The MDR provides that clinical investigations initiated under the MDD or AIMDD rules before 26 May 2020 can continue to be conducted. However, from that date the reporting of serious events and device deficiencies must be carried out in accordance with the MDR provisions.
The MDR has introduced a system of identification and traceability of medical devices – the “Unique Device Identification” (UDI). The UDI is an alphanumeric code created by internationally accepted device identification and coding standards, which manufactures are required to place on the label or packaging of each medical device. This regulatory initiative aims at enabling better device traceability and a higher level of patient safety and transparency in the EU.
Manufacturers’ obligation to place the UDI on the label or packaging of their devices will become applicable in accordance with the following timeline, which depends on the device classification:
- 26 May 2021 for implantable devices and class III devices (if reusable: 26 May 2023);
- 26 May 2023 for class IIa and class IIb devices (if reusable: 26 May 2025);
- 26 May 2025 for class I devices (if reusable: 26 May 2027).
The UDI system will be operated by one or several issuing entities designated by the European Commission by means of implementing acts. The MDR provides that GS1, HIBCC, and ICCBBA will be the issuing entities until the moment the European Commission adopts the corresponding implementing acts.
As we approach the date of application of the MDR, it is key for manufacturers to understand the relevant consequences that every provision may have on their business and prioritise their steps in transitioning to the new regulatory framework.
This post was co-authored by Eftychia Sideri & Marco de Morpurgo.