As we push on the end of the year, and the festive spirit ramps up. It is worth asking “what is on your Regulatory Christmas Wish List this year?”.
I had the pleasure of attending some amazing events this year, including the BIVDA Regulatory Affairs Seminar, RAPS Convergence and Euro Convergence, TOPRA Symposium and MDR Conference, and more recently Medica in Germany. From discussions with various stakeholders, including investors, Notified/Approved Bodies, Competent Authorities and Manufacturers, the challenges of global regulatory burden are getting harder and more complex. The majority of IVD manufacturers are struggling, or have struggled with the implementation of EU IVDR, many have diverted attention to the US market instead.
The IVDR was intended to ensure ‘a high level of safety and health whilst supporting innovation…, taking into account small and medium sized businesses.’ The questioning of this principle with the implementation of the IVDR is not new: this has been a topic of conversation ever since the publication of the IVDR in 2017. But it is a challenge that I keep coming back to.
Here are some key challenges of IVDR compliance for SMEs (from my experience this year):
- Re-classification – For many manufacturers, the engagement with a Notified Body still causes time delays and resource drain. Most NBs now have capacity, and offer guidance on how to complete conformity assessments, but the process is still challenging, and in many cases with an unknowable timeline or probability of success.
- Technical Documentation – Compliance to Annex I, II and II, with a high volume of documentation is needed to demonstrate safety and performance. While many are developing IVDs against the new IVDR framework, many are still struggling the adapt legacy design history and clinical evidence.
- Limited Knowledge & High compliance costs – The SME sector is heavily dependent on limited external funding, and many face a continuous cycle of fund raising. This is being exacerbated by the additional cost of compliance, including consultancy fees, additional headcount and audit fees to get through IVDR conformity assessment. For SMEs, project management of IVDR is typically performed by an external (expensive) or internally on top of an existing role focusing on maintaining or growing a business.
- Market Delay – For many SMEs, a successful outcome is acquisition. However, many investors will not commit to a business until CE marking is obtained, the challenges above put the SME in a precarious position. Some just run out of runway on the route to conformity.
Taking all this into account, it sometimes feels that the EU have swung too far in ensuring a high level of safety, but what is the point in having a world class regulatory framework if you have no devices to regulate? Additional degrees of pragmatism are needed, I think!
Christmas Wish List
2026 promises to be a big year for European regulation (including UK). I would like to see more focus on how we can support SMEs on the journey to compliance.
- Improved structured dialogue – The European commission has recently published the output from the targeted review of the IVDR. I hope we can quickly introduce greater transparency and enable better, more valued dialogue between NBs and Manufacturers. This will help the SMEs gain a better understanding of how they can interpret and conform to the IVDR requirements, especially around clinical evidence and technical documentation.
- Real risk-based classification – Currently I see little practical differentiation between a Class B and C in terms of conformity assessment and technical documentation, especially if you only have 1-2 products coming to market. I would like to see a true risk-based approach in the generation (and review) of technical documentation based on class.
- Sensible approach to CDx and Orphan products – While these device types form a small part of the overall IVDs on market. They play a big part in the healthcare system. The IVDR should be reviewed to ensure that the compliance pathways are clear and unambiguous.
- Early access pathways – For devices with a clear unmet clinical need, a more efficient pathway should be considered to allow SMEs to develop novel devices. An effective adoption process should allow a conveyor belt of safe and effective products through the IVDR process. The EU needs to look no further than the work the FDA and MHRA has done to promote early access pathways.
Christmas is coming, but it does feel a long way off!
When I present at conferences, I always try to reflect on the positives of IVDR. Ask yourself, what do I know now about IVDR, that I didn’t know last year? We have made huge steps forward towards IVDR compliance, more guidance is available and NBs are more engaging and responsive. However, the end goal still feels too far away, but maybe next year we can make some real progress in getting safer products on the EU market whilst supporting innovation.
(AI generated image)