What is the Regulation called?
On 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will become applicable in the EU. It will replace the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) and the related national implementing legislation of individual EEA countries. The IVDR includes transitional provisions for in vitro diagnostic medical devices (IVDs) placed on the EEA market in compliance with the IVDD. These provisions were recently amended by Regulation (EU) 2022/112, which postpones their application to some types of IVDs for a period of time.
What is it about?
The IVDR establishes a new regulatory framework for assessing the safety and effectiveness of IVDs and their marketing in the EEA. It provides for a single set of rules applicable to IVDs being placed, made available or put into service in the EEA. The Regulation strengthens regulatory requirements and introduces new classification rules based on the Global Harmonization Task Force System with four risk based classes – Class A (lowest), Class B, Class C and Class D (highest risk).
To assist manufacturers in adapting to and achieving compliance with the IVDR requirements, the Regulation includes transitional provisions. However, following recent challenges relating to the practical implementation of the IVDR, the transitional provisions have been amended to defer the application of the IVDR requirements for some types of IVDs.
To whom and what does the Regulation apply?
The IVDR applies to IVDs being placed, made available or put into service in the EEA from 26 May 2022.
The amendments made to the IVDR transitional provisions do not postpone the IVDR’s entry into application on 26 May 2022. However, the amendments extend the grace periods for most IVDs that were already placed on the EEA market in compliance with the IVDD. Accordingly, IVDs which are the subject of a valid CE Certificate of Conformity issued under the IVDD prior to 26 May 2022 can continue to be placed on the market or put into service until 26 May 2025. IVDs for which a Declaration of Conformity was issued under the IVDD prior to 26 May 2022 based on a self-assessment but which will be up-classed and require the involvement of a Notified Body under the IVDR for the first time, can continue to be placed on the market until the following dates:
|Risk class||Deadline for placing on the market|
|Class D||26 May 2025|
|Class C||26 May 2026|
|Class B||26 May 2027|
|Class A devices placed on the market in a sterile condition||26 May 2027|
IVD manufacturers may only rely on the transitional provisions above provided that: (i) they respect the IVDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices from 26 May 2022; (ii) the devices continue to comply with applicable requirements imposed by the IVDD; and (iii) no significant changes are made in the design and intended purpose of the devices during the transitional period.
In accordance with the transitional provisions provided in the IVDR, IVDs placed on the EEA market before 26 May 2022 in compliance with the IVDD may continue to be supplied until 26 May 2025. IVDs placed on the EEA market from 26 May 2022, in accordance with the transitional provision above, may continue to be supplied for an additional year after the deadline for placing on the market.
Why does it matter?
The provisions of the IVDD required that only a small percentage of IVDs include the involvement of a Notified Body in the conformity assessment process. The IVDR reverses this approach with most IVD manufacturers required to engage a Notified Body as part of the assessment prior to placing their devices on the EEA market for the first time.
Where can I find the Regulation?
The IVDR can be found here.
Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 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 can be found here.