MDCG published a Notice to manufacturers to ensure timely compliance with MDR requirements.
EU Medical Device Regulations
The EU Regulations entered into force in May 2017 following formal publication in the Official Journal of the European Union (OJ). To allow time for transition to the new requirements, the Regulations become fully applicable over a transition period. The MDR originally provided for a three-year transition period, however, due to the global outbreak of Covid-19, full application of the MDR had been extended and is fully applicable since 26 May 2021.
With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has changed significantly.
The main objectives of these two regulations are to
“establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation”.
Five years have passed since their adoption and the system is being implemented including the development of the joint assessment process for designation of notified bodies, designation of expert panels, publication of harmonised standards as well a large number of guidance documents seeking to help economic operators to comply with their obligations under the Regulations.
The notice published on 13th June 2022 highlights some statistics from the Notified Bodies survey conducted in April 2022. According to the survey more than 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024. To date, 30 notified bodies are designated under the MDR, managing around 80% of current AIMDD/MDD certificates.
Nearly a year back, MedTech Europe noted that in the past 4 years much has been achieved in preparing for the new regulatory framework brought in by the EU MDR. This new infrastructure, however, still has areas that need to be worked out and so, for now, they are only partially operational.
MedTech Europe listed the following challenges that the MedTech industry continues to face:
- Non-harmonized interpretation and application of MDR rules across the EU.
- Limited capacity among notified bodies, especially for certification of new and innovative devices.
- Uncertainties about pending discussions on the rules and agreements between the EU and other countries, especially Switzerland, a key supplier of medical devices to the European Union.
- Unpredictable recognition of MDR certifications at the international level vis-à-vis regulatory approvals from other jurisdictions.
These problems seem to moving away as in this publication MDCG highlights appointment of 30 notified bodies. It also talks about the transition period where the need of Quality Management (QMS) and technical documentation before applying to a notified body is highlighted.
While the MDR has been applicable since 26 May 2021, it provides for transitional provisions allowing medical devices certified under the AIMDD and MDD to be placed on the market until the expiry date of relevant certificates and no later than 26 May 2024. The transition period intends to give further time to the system to prepare and to get ready, for example time for manufacturers to prepare their quality management system (QMS) and technical documentation before applying to a notified body. This step should not be perceived as a “grace period” to postpone the entering into application of the new rules. At this stage, data collected by notified bodies, and presented to competent authorities in December 2021, shows that nearly 37% of manufacturers’ applications have been refused on the basis of incomplete applications, underlining an overall lack of manufacturers’ preparedness.
In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.
From 27 May 2024, the MDR will be fully applicable to all medical devices. Manufacturers are responsible to ensure that their devices comply with the MDR as from the end of the transition period. From that date, medical devices not certified under the MDR will have no access to the EU market.
It should be noted that around 70% of AIMDD/MDD certificates will expire in 2024 (by 26 May 2024 at the latest). Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024.
Derogation from the conformity assessment procedure in accordance with Article 59 of the MDR has been mentioned as a possible remedy in case transition from AIMDD/MDD to MDR is not completed in time. It is important to stress that derogations may be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. This mechanism should not be considered as a solution for cases of late application to a notified body for conformity assessment or delays in the conformity assessment procedure.
Economic grounds alone cannot justify a derogation under Article 59 MDR either. Also other mechanisms provided by the MDR in chapter VII (e.g. to deal with formal non-compliant products) will only be applicable for devices for which the manufacturer can demonstrate that he has undertaken all reasonable efforts to successfully conclude the transition to the MDR, including update of its QMS, in time. In this context, it is expected that the manufacturer has submitted an application to a notified body for certification in compliance with the MDR at least one year before the expiry date of the MDD/AIMDD certificate.
Therefore and in order to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices, it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.
While the regulators have various processes in place for ‘Need of the Hour’ medical devices, Manufacturers should not take this compliance requirement lightly. Key takeaway message from the notice is that
From 27 May 2024, the MDR will be fully applicable to all medical devices. Manufacturers are responsible to ensure that their devices comply with the MDR as from the end of the transition period. From that date, medical devices not certified under the MDR will have no access to the EU market.
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