The date of the definitive application of the Medical Device Regulation (MDR) 2017/745 is close at hand and starting from 26th May 2020 all the Manufacturers will have to comply with several new regulatory requirements.
The current low number of Notified Bodies (NBs) designated for the conformity assessment of medical devices according to the new MDR 2017/745, the resulting long waiting list by these NBs and the reclassification of many class I medical devices in higher risk class with the consequent involvement of a NB in the conformity assessment for the first time would have caused a bottleneck effect for the CE mark applications according to the MDR.
This would have entailed unavoidable delays and the following risk for many Manufacturer of not obtaining the CE mark for their own medical devices in time.
In order to avoid this scenario, on 25th November 2019 the European Council proposed a 2nd Corrigendum to the MDR to the Member States competent authorities and to the European Parliament.
The 2nd Corrigendum has been approved and published on 27 December 2019.
The main change concerns the Article 120 relevant to the transitional provisions. In particular, the paragraph 3 has been changed by extending the so-called Grace Period also to the class I medical devices subject to the up classification with the NB’s involvement according to the new classification rules of the MDR.
The Grace Period is referred to the transitional disposition that allows the medical devices complying with the Directive to be placed on the market until 26th May 2024 and be made available on the market or put into service until 26th May 2025.
However, in order to exploit the Grace Period it is required to fulfil the following conditions:
- The conformity assessment of the class I medical device will require the NB involvement
- A declaration of conformity was drawn up prior to 26th May 2020
- No significant changes in design and intended purpose occurred
According to the 2nd Corrigendum, manufacturers of the class I medical devices subject to up classification will have much more time to prepare the required documentation and apply for the NB’s conformity assessment in order to obtain the CE mark according to the MDR.
Anyhow, it should be highlighted that the Grace Period concerns exclusively the medical devices and it is not addressed to the manufacturers that shall comply with the MDR requirements immediately from 26th May 2020.
This means that all the manufacturers should update their own Quality Management System in order to fulfil the MDR dispositions concerning at least the Post-Marketing Surveillance (for more details click here), the Vigilance (for more details click here), the registration of the economic operators and medical devices, the traceability of the medical devices and the nomination of a Person Responsible for Regulatory Compliance (for more details click here).
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