As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe.
On 5 December 2023, five EU reference laboratories (EURLs) have been designated through Commission Implementing Regulation (EU) 2023/2713 and they will be required to start their activities from 1 October 2024.
According to (EU) 2023/2713, Class D devices are expected to undergo performance verification and batch testing by the EU Reference Laboratory in accordance with Article 100(2). points (a) and (b), of the IVDR.
Performance verification, as part of initial conformity assessment, will only be applicable to devices where applications are lodged with a Notified Body after 1st October 2024 as per Art 2.3, meaning:
• Class D Devices under application or already certified per IVDR, prior 1 October 2024, will not require EURLs involvement in the initial conformity assessment for CE marking.
• Batch verification testing will be applicable from 1 October 2024 for all Class D devices that are already certified or undergoing conformity assessment.
Note that Class D IVDs that fall outside of the scope of a designated EURLs, will continue to be assessed by the Notified Body, through alternative means: no EURLs are involved in the conformity assessment for these devices, at the moment.
Once the designated EURLs will be fully operating, BSI will be actively transitioning Class D devices into the new EURLs 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.
Main steps towards implementation of (EU) 2023/2713 are as follows:
• Drafting of a contract template for obligations and responsibilities between the Notified Bodies and the EURLs, per (EU) 2022/945 and MDCG 2022-3.
• Drafting of a test plan template for determining batch testing regimes between the Notified Bodies and the EURLs, per EU 2022/945 and MDCG 2022-3.
• Update of internal procedures and processes that support the operations of batch verification and performance verification activities, per EU 2022/945 and MDCG 2022-3.
• Notified Bodies updating certification agreements to address the specifics of Article 100 (EU) 2017/746, (EU) 2022/945 and (EU) 2023/2713.
• EURLs will separately define their verification activity fees in accordance with IVDR and (EU) 2022/944.
How can I be prepared?
The publication of (EU) 2023/2713 and the short implementation timeframe has led to challenges for both existing and new IVD manufacturers. IVD Manufacturers will not have a direct contract/agreement with an EURL, as these are independent organizations that will directly liaise with a Notified Body.
The Notified Body will be engaged in the selection of the EURLs and in the development of the test plan as per (EU) 2022/945 and MDCG 2022-3. In preparation of the implementation of EURLs oversight, IVD manufacturers should follow the below steps, depending on the applicable scenario:
• If you intend to transition your Class D IVD to the IVDR, apply as soon as possible with a Notified Body that is designated for Class D devices, like BSI. If you apply before October 1, 2024, Performance Verification is still required, but can happen later in the certification cycle.
• If your Class D IVD is undergoing conformity assessment or it is already certified by the Notified Body through alternative means under the IVDR, ensure compliance to any applicable Common Specifications (CS) as these will feed into the EURL test plan and be prepared to discuss batch release schedule for your Class D devices.
• If you will apply for a Class D IVD with a Notified Body after October 1, 2024, you need to ensure compliance to any applicable CS for EURLs Performance Verification and Notified Body assessment. Batch testing criteria will be confirmed before certificate is issued to enable the batch release activity by the EURLs.
• If your Class D device falls into a category for which an EURL is NOT yet designated, BSI will continue to provide conformity assessment services and batch release activities by the alternative means already in place.
• Legacy Annex II List A IVDs (certified under 98/79/EC) that are eligible to be placed on the EU market, as per the conditions of amendment (EU) 2024/1860, will undergo batch verification activities under the regime of the Notified Body responsible for their appropriate surveillance; while the EURLs provisions will apply to the IVDR devices as described above.
Please note that:
• BSI clients with existing signed agreements that cover Class D IVDs will need to update their certification agreements to cover the EURL specifics of MDCG 2022-3, (EU) 2022/945 and (EU) 2023/2713. BSI will proactively reach out when the updated agreements are made available.
• Clients lodging new Class D applications will be provided with the updated certification agreement, as part of the application and certification process.
Where can I find additional information?
You can visit our IVDR dedicated webpage to access additional information and resources to support you, along with an IVDR transition guidance, timeline and Q&A. If you have additional questions, please contact your Scheme Manager or your Sales Representative.
We have also scheduled a webinar on 26 September 2024, where we will cover these key topics and BSI implementation plans in more details. Please register here.
Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.
Whether you're starting the certification process, looking to transfer or need to discuss your options, we can guide you through the process. Request a quote and start your journey with BSI.
Sincerely,
Alex Laan
Head of the IVD Notified Body
Regulatory Services
BSI
