ECLEVAR UK

ECLEVAR MEDTECH is a global CRO, headquartered in France. We support medical device and IVD manufacturers with the transition to the EU MDR and IVDR by offering following services: clinical evaluation, premarket clinical trials, Post-Market Clinical Follow-up (PMCF) studies, collection of real-life data (RWD) and use of real-world evidence (RWE) to support regulatory submissions.

Eclevar UK seeks to not only support with transition for the EU regulations but to expand its support to the UK regulations both current and new frameworks.

We provide a customizable market access
approach in both global and local markets.

We can help you determine what evidence you need to gather in order to have a successfully launch of your product.

Market access strategies

Clinical evaluation report

First inhuman clinical trials

Registries

Observational study

Survey

UKCA – What are the requirements?

To place a medical device on the market in Great Britain (England, Scotland & Wales), a UKCA will be required.

The UK Medical Device Regulations 2002 (as amended) places in UK Law the three European directives:

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

These are the current requirements for a UKCA mark for medical devices and IVDs. The Medicines and Healthcare products Regulatory Agency (MHRA) are currently updating the UK MDR 2002.

The formal consultation response can be found here.

UKCA

Current routes to market in the UK:

Standstill period (until July 2023)

Manufacturer goes through EU conformity assessment using EU Notified Body

CE Mark

Designated UK Responsible Person (where required)

Manufacturer goes through UK conformity assessment using a UK Approved Body

UKCA Mark

Designates UK Responsible Person (where required)

What do you need to do?

To fully understand the requirements applicable to your product, you need to determine your classification and subsequent route to market. You need to ensure you are compliant with the requirements of the UK MDR 2002.

If you require the input of a UK Approved Body, early engagement is encouraged.

Register your device – all medical devices, IVDs, custom-made devices and systems or procedure packs are required to be registered with the MHRA in order to be placed on the market in Great Britain.

Manufactures based outside of the UK – only UK based manufacturers can register with MHRA, so if you are based outside of the UK you must appoint a UK Responsible Person (UKRP). The UKRP has a number of responsibilities including the MHRA registration. Full responsibilities are set out in the UK MDR 2002. Importers and distributors can act as the UKRP. The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where a product has a UKCA mark affixed.

This is not an exhaustive list!

For further support please get in touch or review the MHRA Guidance

Key dates & Transition

Currently CE marked products are recognised for the GB market as we continue to be in the ‘standstill period’. Standstill is due to end 30th June 2023 and therefore, from 1st July 2023 devices placed on the GB market will need a UKCA mark. This does not leave a lot of time for manufacturers. Within the consultation response, MHRA have proposed some transition timelines which are set out below.

UKCA Marked

Applies to general medical devices and IVDs that hold a valid UKCA certificate/DoC before the new regime takes full effect
Allow products to be placed on the market until either the existing certificate expires or for 3 years (general MDs) or 5 years (IVDs) after the new UK regualtions take effect, whichever is sooner.
Caveats:
devices are subject to significant changes in design or intended purpose will be excluded from these provisions
All post-market requirements applicable to the new framework will need to be complied with for products using the tranitional arrangements.

MDD/IVDD CE marked

Applies to general medical devices and IVDs that hold a valid MDD/IVDD/AIMDD CE certificate/DoC before the new regime takes full effect
Allow products to be allowed on the UK market until either the existing certificate expires or for 3 years (general MDs) or 5 years (IVDs) after the new UK regualtions take effect, whichever is sooner.

Caveats:
devices are subject to significant changes in design or intended purpose will be excluded from these provisions
all post-market requirements applicable to the new framework will need to be complied with for products using the transitional arrangements.

EU MDR/IVDR marked

Applied to general medical devices and IVDs that hold a valid EU MDR or IVDR CE certificate/DoC.
Allow products to continue to be placed on the market until the existing certificate expires or for 5 years after the regualtions take effect, whatever is sooner.
This will apply even if the certificate/DoC is dated after the new UK regulations take effect. However to note the 5 years period remains from when the UK regualtions take effect.
MHRA will review at the 5 year point.

There are also transition proposals for clinical investigations and performance studies:Within the consultation response, MHRA have proposed some transition timelines which are set out below.

Clinical Investigations

Applies to clinical investigations that commence under the current regulations and which would not have completed before the new regualtions take effect.
No requirement to re-apply to MHRA
The ongoing clinical investigation must comply with all reporting requirements set out in the new regulations once they come in to effect.

Performance Studies

No transition provisions
Significant changes in the regulation on performance studies and evalution.

What is Eclevar UK doing to prepare for the new regulations?

Eclevar UK are an active member of the Association of British HealthTech Industries (ABHI) and the British In Vitro Diagnostic Association (BIVDA) – we work with their regulatory groups to support the ongoing work on the new regulations, and ensure we are aware of key updates on the progress.

We await draft legislation and guidance to further inform what the new regulations will be. What we know so far is there is significant alignment with the new EU MDR and IVDR, with some UK specific policies that seek to make the UK an attractive place to develop and market devices and IVDs.

Our team