Transition in Great Britain

Existing regulations state that the acceptance of medical devices marked with CE on the market in Great Britain will cease on June 30, 2023. The government plans to introduce legislation in Spring 2023 to extend the acceptance of CE marked medical devices on the Great Britain market. The purpose of this extension is to ensure the continued safe supply of medical devices to Great Britain and facilitate a smooth transition to the future regulatory framework.

The proposed legislation outlines the following timelines for placing CE marked medical devices on the Great Britain market:

1. General medical devices compliant with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD), accompanied by a valid declaration and CE marking, can be placed on the Great Britain market until either the expiry of the certificate or June 30, 2028, whichever comes sooner.

2. In vitro diagnostic medical devices (IVDs) compliant with the EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) can be placed on the Great Britain market until either the expiry of the certificate or June 30, 2030, whichever comes sooner.

3. General medical devices, including custom-made devices, compliant with the EU Medical Devices Regulation (EU MDR), and IVDs compliant with the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) can be placed on the Great Britain market until either the expiry of the certificate or June 30, 2030, whichever comes sooner.

These provisions will allow certain CE marked medical devices to remain available on the Great Britain market for a longer period.

Transition

For Class I medical devices and general IVDs under the Directives, which did not require the involvement of a notified body for conformity assessment under the EU MDD or EU IVDD, they can only be placed on the Great Britain market if the involvement of a notified body would be necessary under the EU MDR or IVDR. This applies to upclassified devices or reusable surgical instruments Class I devices. Custom-made devices compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.

Manufacturers cannot rely on expired certificates when placing medical devices on the Great Britain market under these transitional measures, unless such certificates have been validated by the EU.

In addition, the government plans to introduce legislation later in 2023 to enforce enhanced post-market surveillance requirements ahead of the broader future regulatory regime. These requirements are expected to come into effect from mid-2024.

Furthermore, the government intends to make an additional amendment in the future. This amendment will state that once the future regime for medical devices is implemented, renewed EU MDR or EU IVDR CE certificates will not be accepted for placing medical devices on the Great Britain market after the full application of the future regime, starting from July 1, 2025.

UKRP

Additionally, medical device manufacturers seeking assistance with registrations and transition processes can rely on the expertise of AF Pharma, a recognized Ukrainian Registration Partner (UKRP). AF Pharma can provide valuable support and guidance throughout the medical device registration and transition procedures. Their extensive knowledge and experience in the field can be beneficial for manufacturers navigating the complexities of regulatory compliance in the Great Britain market.