Ensuring a Smooth Transition: UK Government Extends Timeline for Acceptance of CE-Marked Medical Devices
Authored by Siddhant Shahane, Regulatory Compliance Specialist, Compliance & Risks
This article first appeared in C2P on June 20th 2023
The UK recently published the Medical Devices (Amendment) (Great Britain) Regulations 2023, extending the periods until when manufacturers can place CE-marked medical devices on the GB market.
This instrument provides the UK medical devices sector with additional time to transition to the post-EU exit UK Conformity Assessed (UKCA) marking regime for medical devices. By doing so, the UK aims to ensure a continued supply and availability of medical devices to safeguard the health needs of patients.
The territorial application of this instrument (that is, where the instrument produces a practical effect) is Great Britain only. Great Britain is England, Wales and Scotland.
Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain, more information on this can be found at the bottom of this commentary.
Labelling & Extended Timelines
Since 1 January 2021, to place medical devices on the GB market, manufacturers have had the option to either utilize the UKCA route to market or to continue to comply with EU legislation.
The government has now introduced measures to extend acceptance of CE-marked medical devices in Great Britain beyond 30 June 2023. The measures will provide that CE-marked medical devices may be placed on the Great Britain market according to the following timelines:
- general medical devices compliant with the EU MDD or EU AIMDD can be placed on the Great Britain market up until the sooner of expiry of the certificate or 30 June 2028
- IVDs compliant with the EU IVDD can be placed on the Great Britain market up until the sooner of expiry of the certificate or 30 June 2030, and
- general medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030.
Exceptions to the Extended Timelines
This would enable certain CE-marked medical devices to continue to be placed on the Great Britain market for longer. The above timelines will not apply to Class I medical devices and general IVDs under the EU directives, where the conformity assessment under the relevant directive and under the EU MDR or EU IVDR does not involve a notified body. Similarly, they will not include custom-made devices that are compliant with the EU MDD or EU AIMDD.
This would mean that you can place self-declared CE-marked Class I medical devices on the Great Britain market beyond 30 June 2023 if they are
- self-declared against EU MDR requirements (until 30 June 2030), or
- self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes unclassified devices and reusable surgical instruments.
You can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.
Conformity Assessment Certificate
Certificates issued by EU-recognized Notified Bodies that are valid for the EU market, will continue to be recognized as valid for the UK market.
UK Responsible Person
Devices can have both the CE and UKCA markings present on the labelling. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).
Requirements for Northern Ireland at a Glimpse
- Since 26 May 2021, the EU MDR has applied in Northern Ireland. The EU IVDR has applied in Northern Ireland since 26 May 2022.
- CE marking is required for the Northern Ireland market. In addition, the UKNI indication is required if a UK Notified Body undertakes mandatory third-party conformity assessment.
- Certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the MHRA.
- All custom-made devices must be registered with the MHRA within 28 days of being made available on the Northern Ireland market.
- When placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorized Representative.
For more information on the regulatory system for medical devices in Northern Ireland, please see this guidance.
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