DIAGNOSTICS
are experiencing, making it difficult to achieve regulatory conformity. This is resulting in many EU MDD, IVDD and AIMDD certificates lapsing without a regulatory alternative for the market, halting their supply. If the UK system is to rely on CE certificates, it would therefore also rely on the EU Notified Body network.
Even if manufacturers do opt to gain UKCA marking to the current UKCA regime prior to implementation of the new UK Regulations, this relies on the same pool of conformity assessment bodies to conduct assessments; of the four Approved Bodies in the UK, three of these are also Notified Bodies in the EU.3-5
The benefit to using the existing
The new transitional arrangements for CE marked products are dependent on the EU documentation being valid.
date is soonest)
n Transition for CE IVDD products*: Can continue to utilise CE declaration of conformity to place on the GB market until 2030, or until expiry of the certificate (whichever date is soonest).
n Transition for CE MDR or IVDR products: Can continue to utilise CE declaration of conformity to place on the GB market until 2030.
* Class I medical devices and general IVDs are now only able to be placed on the market in the EU under an EU MDD or EU IVDD declaration of conformity where they are being upclassified. Otherwise, they must be compliant to the EU MDR or EU IVDR.
The transitional arrangements for CE marked products are dependent on the EU documentation being valid. If there is a device which is taking advantage of the transitional arrangements of the EU MDR or IVDR, the ‘expiry date’ of the CE MDD, IVDD or AIMDD declaration of conformity will be the transitional date. As an example, for a product which
is currently considered a self-test IVD under the EU IVDD, and would be considered Class C under the EU IVDR (being up-classified from the second lowest risk classification to the second highest risk classification), the declaration of conformity will expire on 26 May 2026 in line with the EU IVDR transitional timelines. As this will no longer be a valid declaration of conformity in the EU (and therefore in Great Britain), an EU IVDR declaration of conformity, or a UKCA declaration of conformity (new UKCA regime) is needed from 27 May 2026 to continue supplying to the GB market.
What do you need to know as a pathology professional? The main impact that could result from these changes is a shortage of products for UK hospitals and laboratories. In the EU, conformity assessment reviews are taking longer than expected due to the increased requirements under the new EU Regulations. The number of Notified Bodies doesn’t match the demand they
The main impact that could result from these changes is a shortage of products for UK hospitals and laboratories. In the EU, conformity assessment reviews are taking longer than expected due to the increased requirements under the new EU Regulations
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UKCA regime hinges on the reduction of products requiring conformity assessment from an Approved Body. It is estimated that 80% of IVDs under the EU IVDD do not require conformity assessment from a Notified Body, whereas 80% of IVDs under the EU IVDR do require conformity assessment from a Notified Body.6
This
is due to the classification changes introduced for IVDs under the EU IVDR. The Government plans for UKCA classification of IVDs seems to align more closely with the European model (whilst still having some differences), meaning that this shift in conformity assessment is likely to also impact products going through the new UKCA regime. It is crucial that laboratories across the UK understand that – until at least 2030 - IVD products with a CE mark are accepted in the Great Britain market, and we are likely to see a mix of CE and UKCA marks for valid products. Notably, for Northern Ireland the CE mark is mandatory, but products can be dual marked with both the CE and UKCA marks to access both the Great Britain and Northern Ireland (EU) markets. Products need to comply with regulations when they are first placed on the market, so any stock already on the market can continue to be used regardless of their certification.
These new proposals specifically are unlikely to have an impact on laboratory developed tests. There is currently no transitional period listed for such tests under any GB legislation or guidance, so it can be assumed that they will need to meet any new requirements from the new date of application. It is still unclear what these new requirements will be, or when this new date of application will be.
Summary
These new transition periods for medical devices and IVDs have
JUNE 2023
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