IVDR amendments and Policy regarding Class D IVDs

Date: 20 March 2023

On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect. The objective of the amending Regulation is to address the projected imminent risks of shortages of medical devices in EU due to the slower than anticipated transition from the medical device Directives to MDR and IVDR.

IVDR amendment

The sell-off provisions specified in IVDR Article 110.4 have been abolished to allow legacy IVD medical devices already placed on the market under the Directives to be made further available without an end date.

BSI on implementing Regulation (EU) 2022/112, including latest IVDR amendment

BSI welcomes the latest Regulation Amendment, as well as the Regulation (EU) 2022/112 published last year as they ensure market access to safe IVD medical devices while providing additional time to manufacturers and Notified Bodies to complete the transition of devices to the IVDR. BSI is working internally, and in parallel, working very closely with the EU Authorities, and other Notified Bodies to develop common understanding of the new amending Regulation, develop relevant templates and to support harmonised implementation of the new amending Regulation across all Notified Bodies.

The most important timelines, including the previous amendment (EU) 2022/112, are as follows:

Policy on Class D IVDs, pending designation of European Reference Labs (EURLs)

As you are already aware, BSI has adopted a risk-based Class D transition strategy whereby we are actively engaged in conformity assessment of devices. We are adopting the measures described in Team-NB/NBCG Med Position Paper case-by-case depending upon manufacturers conformity assessment history, device risk and novelty of technology.

While we wait for EURLs to be designated, BSI is committed to exploring ways to mitigate the risk of certifying Class D devices without independent laboratory verification and without reducing the level of scrutiny advocated under IVDR. Once EURLs are designated, we will be actively transitioning Class D devices into the new framework.

Manufacturers are recommended to not postpone/delay their IVDR plans

In order to make full use of the currently available capacity for completing the IVDR transition, BSI strongly recommends that manufacturers who have already made or planned their IVDR applications and documentation submissions with BSI according to January 2022 legislation, do not deviate from their plans, and strongly urges other manufacturers who are yet to make their IVDR applications to submit them as soon as possible for the following reasons:

• Delaying or changing your current planned submissions will mean that the submissions will be added to the end of the review queue, thus facing the risk of delayed conformity assessment and possible risk of not completing the work before the end of the transition period
• Manufacturers are not allowed to make significant changes to the design or intended purpose to their legacy devices during the transitional provisions

Technical Documentation work is allocated to reviewers qualified to the specific IVR/IVP/IVS/IVD codes (or combinations thereof) applicable to each submission, so the lead time for allocation and commencement of a review is variable depending on the existing and incoming workloads. We will schedule and conduct reviews at the earliest opportunity based on availability of reviewers. During a review, responding to questions in a timely manner will ensure the cadence of your review schedule is as efficient as possible.

Please be assured we are focusing on our capacity of reviewers to be able to meet the demands for certification as efficiently as possible.

Where I can find additional information?

You can visit our IVDR dedicated webpage to access additional information and resources to support you. If you have additional questions, please contact your Scheme Manager.

Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework. BSI would like to thank you for all your efforts and the progress made over the last few years, and looks forward to working with you in completing your Regulation transitions in a timely manner.

Sincerely,

Alex Laan
Head of the IVD Notified Body