IVDR Transition Timelines Extended

[Contenuto in lingua inglese]

On 9 July 2024, the Regulation (EU) 2024/1860 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 in vitro diagnostic medical devices in EU due to the slower than anticipated transition from the In Vitro Diagnostic Directive (IVDD) to the IVDR.

In addition to the removal of the sell-off provisions specified in Article 110.4 made official with Regulation (EU) 2023/607 on 20 March 2023, this new Amending Regulation aims to guarantee patient care by ensuring the availability of IVDs, without compromising safety requirements.

The new Amending Regulation extends the IVDR transition timelines while also recognizing as valid previously issued IVDD Certificates for the duration of those longer transition timelines. This allows manufacturers to continue placing their devices on the market based on compliance to the Directive and to IVDR Art 110 provisions, while they continue transitioning their devices to the IVDR. However, it is important to note that the extended transition timelines apply only to devices that are transitioning to the IVDR and meet additional specific conditions set out in the Regulation. These conditions are aimed at ensuring that the manufacturer has taken appropriate steps to transition to the IVDR. A summary of the salient points from the new Amending Regulation is outlined below.

Key elements of the new Amending Regulation

The table below shows the new transition timelines that apply for different IVDs classes subject to the following conditions:

• Compliance with Directive 98/79/EC and no unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health
• No significant changes implemented in the design or intended purpose of the device
• No later than 26 May 2025, the manufacturer has put in place an IVDR compliant QMS
• No later than the applicable deadlines below, the manufacturer has lodged an IVDR application and has signed a formal written agreement with a Notified Body

*Conditional to certificates validity (Art 110(2)).

You can consult the updated IVDR transition timeline here.

Given the above conditions, devices covered by IVDD Certificates that were valid as of 26 May 2022, but expired prior to the publication of this new amending Regulation benefit from the longer transition timelines (as shown in the table above) only if the manufacturer had applied for IVDR and signed a formal written agreement prior to the expiry of those Directive Certificates or a derogation/exemption has been granted by a Competent Authority under either Article 54 or Article 92 of the IVDR.

In cases where the manufacturer has their IVDR application with a different Notified Body to the one that issued the Directive Certificate, the Regulation allows the IVDR Notified Body to take over the appropriate surveillance of the devices covered the Directive Certificates issued by the other Notified Body, subject to an agreement between the two Notified Bodies and the manufacturer. However, the Notified Body designated under Regulation (EU) 2017/746 is not considered responsible for conformity assessment and surveillance activities carried out by the Notified Body that issued the IVDD certificate.

Manufacturers 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 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:

• Only those devices transitioning to the IVDR benefit from the longer transition timelines and extended validity of the Directive Certificates for those devices.

• 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.

• Manufacturers are not allowed to make significant changes to the design or intended purpose of their devices under the Directive even under the longer transition timelines.

• For those manufacturers intending to transition their devices to IVDR and are yet to submit their applications, BSI may not be able to process your application in a timely manner if it is submitted very close to the application cut-off timelines due to the anticipated rush of last-minute applications thus facing the risk of not benefitting from the longer transition timelines.

BSI on implementing the new Amending Regulation

BSI welcomes the new Amending Regulation as it ensures market access to safe in vitro diagnostic medical devices while providing additional time to manufacturers and Notified Bodies to complete the transition of their devices to the IVDR.
BSI has already started working to implement the new amending Regulation into our own Quality Management System and operational processes and expects to complete these activities as soon as possible but in a phased manner depending on the priority of the changes/provisions to be implemented. In parallel, BSI is also working very closely with the EU Authorities, and other Notified Bodies to develop common understanding of the Regulation, develop relevant templates and to support harmonized implementation of the new amending Regulation across all Notified Bodies. Please be assured we are focusing on our capacity of reviewers to be able to meet the demands for certification as efficiently as possible.

Policy on Class D IVDs, following 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 high-risk 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.

On 5 December 2023, a number of EU reference laboratories (EURLs) have been designated through Commission implementing regulation (EU) 2023/2713 and will be required to start their activity from 1 October 2024.

Once the designated EURLs will be actively operating, we will be actively transitioning Class D devices into the new framework. BSI will continue to work towards smooth and timely transitions into EURLs throughout 2024, while developing a consistent approach for performance verifications and batch tests on Class D devices. Meanwhile, 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.

Where can I find additional information?

You can visit our IVDR dedicated webpage to access additional information and resources to support you, along with a IVDR transition guidance and a Q&A on most frequently asked questions. If you’ve additional questions, you can email us at medicaldevices@bsigroup.com.

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
Regulatory Services, BSI