75% IVDs may Lack IVDR Certification!
Recently, MedTech Europe, a European trade association for the MedTech industry, including diagnostics, devices and digital health, issued a warning.
MedTech Europe had organised a survey in July 2021 where they collected data from IVD manufacturers to identify the state of the IVD market and understanding transition preparedness. This survey represents 90% market revenue coverage and has developed new insights for the industry.
Because of the incoming IVD Regulations [IVDR], nearly 22% of IVD tests will be discontinued. Companies will face a challenging time to comply with these regulations, and non-compliant products will be immediately taken off the market. Additionally, a huge chunk of companies will fail to transition their products and will not receive certification by the deadline of 26th May 2022.
Amongst the product discontinuation numbers comes the small and medium-size organisation that produce small quantities of niche products. These small manufacturers with a small quantity of niche devices will soon run out of business because of regulatory complications. From the survey data, MedTech Europe estimates a best-case scenario where 61% of today’s IVDs will be certified by 26th May 2022 and a worst-case scenario where only 24% will (see Figure 1).
Figure 1: IVD Regulation certification forecast for 27 May 2022 based in July 2021 survey data published by MedTech Europe.
What are the fundamental causes of these challenges and manufacturers going out of business?
Well, after detailed summarisation of the report and interaction with stakeholders, our experts could identify that:
- Nearly 88% of IVD certificates are yet to be issued by the notified bodies. [10 months before deadline date].
- Some IVDs would require certificate(s) from 2 or more notified bodies.
- Lack of regulatory pathway. 53% of manufacturers have not yet initiated a regulatory roadmap that ensures the continuation of their products on the market shelves.
- 53% of manufacturers are unable to sign and certify their quality management system and IVDs with the Notified Bodies.
- Despite having 28 notified bodies, 64% of SMEs don’t have contracts with any notified bodies.
Because of these reasons, any product not complying with the requirements will be discontinued from market shelves with effect from 27th May 2022 (transitional provisions may apply but are limited in scope). It’s not just the regulators creating these challenges, but manufacturers are equally responsible as 74% of manufacturers reported that they are facing issues in starting or completing certifications.
According to Euro Roundup by RAPS done on 16th September 2021
MedTech Europe now forecasts that 22% of IVDs will unavoidably be lost in the transition to IVDR. A further 17% of IVDs will definitely not be certified in time. MedTech Europe calculates 24% of IVDs will either have an IVDR certificate or be allowed on the market based on self-certification because they are low risk.
That leaves 37% of IVDs with uncertain futures. Depending on what happens in the coming months, MedTech Europe forecasts that as few as 24% or as many as 61% of IVDs may be certified by the time the law takes effect.
Notified body capacity is a significant barrier to hitting the upper end of the range. The survey found 53% of IVD manufacturers and 64% of small and medium-sized enterprises cannot engage with a notified body to certify their IVDs and quality management systems. MedTech Europe is calling for urgent action to ensure “that a minimum viable infrastructure is in place.”
Our expert and company Director, Mrs Greer Deal, stated “the IVD sector has had 5 years to transition from the ‘old’ Directive to the ‘new’ Regulation so it is concerning to hear that many companies have not even started this process and yet the 26 May 2022 is now only just around the corner. But, and it is a big ‘But’, I don’t think anyone realised, or appreciated, the impact of the new regulation on Notified Bodies. Some have pulled out altogether and for others it’s taking a long time to get them designated under the IVDR. Compound this with a severe shortage of resource and 80% of IVD companies needing to engage a Notified Body, the future is looking ‘painful’ at best. It is critical that IVD companies plan now and implement contingency strategies to ensure they stay in business and remain viable.”
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