IVDR Regulation Amendment Update
25/1/2022
In response to the proposal sent on 14.10.2021 with regards to a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices.
The European Union on 25th January 2022 passed a Regulation in which came into immediate effect –
Regulation of the European Parliament and of the Council amending regulation (eu) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.
This regulation
- Establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices covered by that Regulation.
- Considers the ongoing challenges of COVID 19 and under Those extraordinary circumstances have a significant impact on various areas covered by that Regulation, such as the designation and work of notified bodies and the placing on the market and making available on the market of in vitro diagnostic medical devices in the Union.
- Addresses the need of uninterrupted market supply of In vitro diagnostic medical devices which are essential to the health and safety of Union citizens, and SARS-CoV-2 tests.
- Addresses unprecedented magnitude of the current challenges, the additional resources needed by Member States, health institutions, notified bodies, economic operators and other relevant parties in order to fight the COVID-19 pandemic and the currently limited capacity of notified bodies, and taking into account the complexity of Regulation (EU) 2017/746, it is very likely that Member States, health institutions, notified bodies, economic operators and other relevant parties will not be in a position to ensure the proper implementation and full application of that Regulation from 26 May 2022 as laid down therein.
- Understands The current transitional period provided for in Regulation (EU) 2017/746 regarding the validity of certificates issued by notified bodies for in vitro diagnostic medical devices under Directive 98/79/EC will end on the same date as the transitional period provided for in Regulation (EU) 2017/745
- Addresses: In order to ensure the smooth functioning of the internal market and a high level of protection of public health and patient safety, as well as to provide legal certainty and avoid potential market disruption, it is necessary to extend the transitional periods laid down in Regulation (EU) 2017/746 for devices covered by certificates issued by notified bodies in accordance with Directive 98/79/EC
- States that - As regards the period of time needed to expand the capacity of notified bodies, a balance should be struck between the limited available capacity of such bodies and ensuring a high level of public health protection. Therefore, the transitional periods for in vitro diagnostic medical devices that are to undergo conformity assessment involving a notified body for the first time under Regulation (EU) 2017/746 should be such as to allow differentiation between higher-risk and lower-risk devices. The length of the transitional period should depend on the risk class of the device concerned, so that the period is shorter for devices belonging to a higher risk class and longer for devices belonging to a lower risk class.
- In order to allow in vitro diagnostic medical devices which have been lawfully placed on the market, the sell-off date of 27 May 2025 provided for in Regulation (EU) 2017/746 should be adapted to take into account the additional transitional periods provided for in this Regulation.
- Having regard to the resources required by health institutions in the fight against the COVID-19 pandemic, those institutions should be given additional time to prepare to meet the specific conditions for the manufacture and use of devices within the same health institution (‘in-house devices’) laid down in Regulation (EU) 2017/746. The application of those conditions should therefore be deferred.
- Since the objectives of this Regulation, namely to extend the transitional periods set out in Regulation (EU) 2017/746, to introduce additional transitional provisions in that Regulation and to defer the application of the provisions of that Regulation concerning inhouse devices
- The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 pandemic and the associated public health crisis. It is therefore considered to be appropriate to provide for an exception to the eight-week period.
- In light of the overriding need to immediately address the public health crisis associated with the COVID-19 pandemic, this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union,
The new Amendments:
- ‘27 May 2024’ is replaced by ‘27 May 2025
- Devices with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 26 May 2025.
- Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:
- (a) 26 May 2025, for class D devices;
- (b) 26 May 2026, for class C devices;
- (c) 26 May 2027, for class B devices;
- (d) 26 May 2027, for class A devices placed on the market in sterile condition
- By way of derogation from the first subparagraph of this paragraph, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in the second and third subparagraphs of this paragraph, instead of the corresponding requirements in Directive 98/79/EC.
- Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025. Devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service until the dates mentioned in the amendment.
The Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices.
Was drafted because of
- One of the main changes concerns the involvement of independent conformity assessment bodies (‘notified bodies’). Currently, only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) is subject to notified body control under Directive 98/79/EC
- Under the Regulation, around 80% of in vitro diagnostic medical devices will be under the control of notified bodies, the vast majority of them for the first time5 . That means that manufacturers will need to apply to a notified body and obtain one or more certificates after completion of the appropriate conformity assessment procedure, before being able to place their devices on the market. On average, a conformity assessment procedure takes around 1 year, after which additional time (around 6 months) is needed to produce the devices and prepare them for release on the market, according to information provided by the medical device industry.
- Only devices that require a notified body certificate already under Directive 98/79/EC (around 8%) will benefit from these transitional provisions. This Commission proposal builds on those existing transitional provisions by extending their scope and timelines.
- These extraordinary circumstances (COVID 19) have demanded substantial additional resources from Member States’ competent authorities, health institutions, notified bodies, manufacturers and other economic operators to increase the availability of vitally important medical diagnostics.
- Data on market readiness collected by the European Commission during the first half of 20217 show that members of the ecosystem will not be in a position to ensure the proper implementation and application of the Regulation from 26 May 2022 especially because there is a grave shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time
Owing to the proposal, this regulation came into the effect from 25th January 2022
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