Entering the Twilight Zone for legacy products

With the final steps of the approval of the new EU-MDR and EU-IVDR being moments away, the debates are moving to understand the impact and ramifications of the hard and soft transitioning specifications. Industry lobby fought hard to get more time for the transitioning, and they succeeded. Somewhat at least…

In the Twilight Zone of the soft transitioning phase, many new requirements will be applicable to legacy products. The most challenging ones will be to compare to state of the art and to ensure on the other hand no changes in the product occur that would need to be listed on the old MDD-based CE certificate.

Following publication of the EU-MDR in May/June 2017, 20 days and 3 years later the legislation fully applies. All products that are envisaged to stay on the market long term should have an MDR certificate in place, and those that are being sold out have 5 years left for those products produced and packaged before the end of the transition period, utilizing the old MDD certificate. Yet article 120 provides another escape ad interim, which will allow manufacturers to continue to actually produce products under the scope of their old MDD CE certificate for a period up to 4 years. But only under very harsh conditions. As manufacturer, you will need to apply all new MDR rules, relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices, whereas for all other requirements the old MDD should be followed. And secondly, there should be no significant changes in the design and intended purpose of the devices. Should they be there, than the temporary allowance stops, and the product approval status turns dark.

In reality this means there are two big restrictions in continuing to produce the medical devices and deliver them to the market. The first of them is clear: the product should be made in accordance with the design and production methods as specified and agreed with the Notified Body that issued the certificate. Clearly that means that only products under an MDD certificate can use this path, no class I product exemptions. But also it means that the product list underlying the MDD CE certificate on the day of application of the EU-MDR will be crucial as it restricts the products that may remain being produced in the soft transitioning zone. Including all details specified on the certificate, as the notified body will no longer be able te re-issue the certificate. So, no changes in legal manufacturer, address, listed subcontractors etc. will be possible. And the notified body will need to stay in place to supervise the certificate and perform conformity assessments. Any of these changes might actually create a hard stop to the soft transitioning for an individual product. However, even in such case, the products still in the warehouse may be placed on the market until the end of the 5 years sell-of-stock period allowed generally.

The second restriction is much more influential. It concerns the conflict the above scenario has with the newly introduced concept of State of the Art that is now linked to the clinical performance of the product. With the new view on continuous improvement of the medical devices as well as the documentation on their safety and performance that is underpinning the new EU-MDR, the anticipation is that the State of the Art expectations will be more continuously improving compared to the current framework where State of Art is being revisited with certificate renewal and/or when new versions of harmonized standards are being published. As a result, a well implemented MDR-based QMS system will fully integrate the PMS data collection and analysis with improvements to risk management, validation, clinical evaluations and more, with the aim to continuously learn from the market to improve the products.  Doing the data collection and assessment, without being allowed to change and improve the product will in relatively short term bring up the debate if older products still can be seen as safe enough given the enhanced state of the art. In essence that means that for product categories where state of art is changing rapidly, it will be hard to continue producing the products as the gap with the expectations will be increasing, changing risk benefit ration in favor of the growing risks.

Adding to that the notions that using old MDD certificates after the transition period ended for market registrations outside of EU, for tenders inside and outside of the EU, and other official use outside of the formal scope of CE-marking, it is evident that the 4 years additional time are to be used with care. Key will be in the implementation plan to focus on 3 years to get to full compliance for all products that should go into MDR, whilst allowing the 3+5 years sell out of stock for products that will be phased out. Additional products can be generated in the 3+4 years, assuming every day of production may be the last one. In that way the period can be used to backfill the residual supply in the warehouse that is the best estimate of the quantity of MDD-certified products needed to last until summer 2025.



More information about the writer:

Gert W. Bos, PhD, Fraps
Post date: April 12, 2017
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