Regulatory Open Forum

Hi All,

Hi Kristina, 

If I understand correctly, as you mentioned, EU clinical labs are handling IVDR Article 5 and Annex I (GSPR) requirements and expectations from manufacturers are :

For Clinical Laboratories:

1. Use CE-Marked IVDs: Labs must use IVDs with the CE marking that comply with IVDR.

2. Quality Management System: Implement ISO 15189:2012 and maintain a quality management system.

3. Validation and Verification: IVDs are validated and verified for accuracy in their specific setting.

4. Reporting: Report adverse events related to IVD use to authorities.

5. Record-Keeping: Maintain records of test results and quality control.

For Manufacturers:

1. GSPR Compliance: IVDs meet General Safety and Performance Requirements (GSPRs) in Annex I.

2. Clinical Evidence: Generate clinical data to demonstrate safety and performance.

3. UDI: Assign and manage Unique Device Identifiers (UDIs).

4. Quality Management: Establish ISO 13485:2016-compliant quality management systems.

5. Technical Documentation: Maintain detailed technical documentation.

6. Notified Body: Engage with notified bodies for CE certification.

7. Post-Market Surveillance: Monitor and report device safety and performance in the market.Both parties must meet the regulatory requirements, and compliance is essential for market access in the EU, transitional provisions and deadlines for bringing existing IVDs into compliance with the IVDR. please double-check if they are correct.

Yes I do. I work for a number of labs that are implementing this. The manufacturer's requirements are not determined by article 5 (5) as this only determines the conditions under which health institutions can manufacture and use in house devices within the health institution.

What I have seen so far is that labs do not really have issues obtaining the information they need for their Annex I GSPR file (although this may be because they are not going deep enough on this) but rather have a lot of issues setting up the required QMS (especially hospital labs fight this tooth and nail and want to shoehorn everything into ISO 15189 of which the MDCG has already said it's NOT an adequate manufacturing QMS as such).

Also, commercial labs have issues with the competent authorities in member states because these tend to try and restrict use of inhouse tests to the patients in their member states and discourage cross border testing (against which there is no hard and fast prohibition in my view).

Let me know if you need any help with this for your lab.

Hi Erik:

Thank you for your feedback on this, it's very helpful as we start to navigate this pathway.  It's good to hear that labs are not having any issues yet in obtaining the evidence to support the GSPR.  I hear your point that labs may be covering the minimum requirements at this point as the Annex 5 has not fully gone into effect.

A really complex article that applies to so many situations.

I would echo alot of what Erik has stated.

I would agree on 15189 and the benefit in using it, I have heard of multiple labs now using 13485 (limited in some ways at times) and hospitals and HI's also have 13485 in place 

For manufacturers I would also no look at Art 5 in isolation, it definitely needs to be considered with Art 6 and 7 and then with Art 10.

From the EU side. This is getting visibility, there is a Distant Sales task force currenlty being set up to look at this, it will hopefully lead to a guidance doc at some stage.

There is also work being done on a definition for what constitutes a Health Institute as currently this differs from member state to member state.

Hi Tom:  Thank you for your feedback!  I agree that additional guidance on these topics would be critical for implementation as there can be several interpretations.