The European Commission published a formal proposed amendment [COM(2021)627] to the In Vitro Diagnostic medical devices Regulation (EU) 2017/746 (IVDR) on 14 October 2021 which specifically updates the transitional provisions in Article 110. This is good news for IVD manufacturers, who have long been hoping for additional time in order to meet the new requirements and obligations of the Regulations. This will need to be put forward for a formal vote and will be applicable after it has been published in the Journal of the European Union.
The proposal provides a lengthy explanation for the extension. Whilst stating that the COVID-19 pandemic has confirmed the need for a robust regulatory framework for in vitro diagnostic medical devices in the EU, it is also had a negative impact on the implementation of the IVDR. A shift in priorities and travel restrictions impeded the progress of the Commission and other stakeholders in the EU, thus leading to a general unpreparedness for the IVDR’s original date of application, 26 May 2022.
The Commission estimated that conformity assessment procedures could take up to a year to complete, after which it would take on average 6 months to produce the IVDs and place on the market. With only a handful of Notified Bodies designated towards the IVDR, and given the fact that an estimated 80% of IVD medical devices will require Notified Body intervention under the Regulation, the industry has long been calling for an extension. Enforcing the 26 May 2022 deadline would no doubt culminate in a perfect storm of IVD shortages on the market, having a disastrous effect on the healthcare industry and patient wellbeing.
It is being proposed that Article 110(2) be amended such that certificates issued in accordance with the IVD Directive 98/79/EC (IVDD) shall become void at the latest on 27 May 2025, giving these a one-year extension. Paragraph 3 of Article 110 will be replaced by the following:
(3) By way of derogation from Article 5 of this Regulation, the devices referred to in the second and third subparagraphs of this paragraph may be placed on the market or put into service until the dates set out in those subparagraphs, provided that from the date of application of this Regulation they continue to comply with Directive 98/79/EC and provided that there are no significant changes in the design and intended purpose.
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.
However, 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 first, second and third subparagraph instead of the corresponding requirements in Directive 98/79/EC.
In summary, an IVD medical device compliant with the IVDD and holding a Notified Body certificate, will have till the end of the validity period of that certificate, and can be placed on the market or put into service until 26 May 2025.
For devices which did not require a Notified Body under the IVDD (as in the case of ‘General IVDs’) and whose conformity assessment procedure under the IVDR will now require Notified Body intervention, the transition period has been staggered depending on their risk classification.
Paragraph 4 of Article 110 has also been amended and gives further provisions for when IVDD-compliant devices may remain on the market or put into service.
(4) 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 following dates:
(a) 26 May 2026 for devices referred to in paragraph 3, second subparagraph, or in paragraph 3, third subparagraph, point (a);
(b) 26 May 2027 for devices referred to in paragraph 3, third subparagraph, point (b);
(c) 26 May 2028 for devices referred to in paragraph 3, third subparagraph, points (c) and (d).’;
We recommend reviewing the below definitions from the IVDR to fully understand the above:
‘making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market;
What constitutes a significant change? The EU’s Medical Device Coordination Group (MDCG) released guidance document ‘MDCG 2020-3’ which explains in some detail what is considered to be a significant change in relation to the Medical Device Regulation (EU) 2017/745 (MDR) Article 120(3). This may be extrapolated for use to explain significant changes in relation to IVDs. The MDCG guidance provides a series of flowcharts which may be followed to determine whether the change to design or intended purpose would be considered significant or not. Such changes should always be discussed on a case-by-case basis with the relevant Notified Body, however, the following changes would not be deemed significant:
- Reductions or limitations of the intended purpose.
- Design changes related to corrective actions assessed and accepted by the Competent Authority.
Importantly, IVDs which did not require Notified Body intervention under the IVD Directive and which will be classified as Class A under the IVDR will need to transition to the IVD Regulation by 26 May 2022 in order to place these on the market after that date. This also applies to ‘new IVDs’ which do not have a Declaration of Conformity or valid certificate dated prior to 26 May 2022. We encourage all manufacturers of Class A non-sterile devices to meet the requirements as soon as possible to avoid issues in placing your products on the market.
For manufacturers who will benefit from the extended transition period introduced by Article 110(3), you will still need to comply with certain sections of the IVDR, as specified above. The following technical documentation updates will be required as a minimum:
- Updating the Post-Market Surveillance (PMS) Plan in accordance with Annex III.
- Developing a PMS Report or a Periodic Safety Update Report (PSUR).
- Updating existing procedures on vigilance to meet the requirements in Chapter VII Section 2. Of note is that ‘other’ adverse events shall be reported within 15 days rather than 30 days under the previous Directives.
These changes must be implemented within the technical documentation and QMS from 26 May 2022.
The following amendments to the IVDR will also be made:
- Article 112, second subparagraph, the date ‘27 May 2025’ is replaced by ‘26 May 2028’.
- Article 113(3), the following points (i) and (j) are added: ‘(i) Article 5(5), points (b), (c) and (e) to (i), shall apply from 26 May 2024; (j) Article 5(5), point (d), shall apply from 26 May 2028.’.
The latter points in Article 113(3) (i) and (j) will be positive for those devices being manufactured and used only within health institutions, effectively providing an extended grace period and more breathing room for them to meet the obligations of Article 5(5) of the IVDR.
How can Advena help you?
Advena has well over 20 years of professional experience within the medical device industry as both a leading EU Authorised Representative and regulatory consultants. We are able to guide you through the complexities of EU regulation and help you place compliant devices on the market:
- Regulation Gap Analysis for Directive-compliant technical documentation and QMS.
- Regulation-compliant technical documentation.
- Regulation-compliant QMS.
- EU Authorised Representative service under the EU Regulations.