just released: Updated transitional arrangements for UKCA process
On 28 April 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) published a communication updating previous information on the extension period for the mandatory implementation of the United Kingdom Conformity Assessment (UKCA) process for medical devices. This update is resultant from the recent amendment by the EU Commission (EU 2023/607) to extend the transition period for MDR 2017/745.
Currently, CE-marked medical devices with valid CE marks maye be placed on the Great Britain Market until 30 June 2023; the Great Britain market consists of England, Wales and Scotland. Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain. In practice, Northern Ireland must still follow the requirements of the EU, so is not affected by these changes.
You can review the full communication here: Regulating medical devices in the UK – GOV.UK (www.gov.uk).
On 14 November 2022, the UK Government announced that CE marking would be accepted in the UK until 31 December 2024 instead of 31 December 2022. However, this relates to CE marking in other sectors, not medical devices, which have separate and different requirements.
Subject to Parliamentary approval, legislation will be introduced before 30 June 2023, which will provide that CE-marked medical devices may be placed on the Great Britain market to the timelines defined below.
New Transition Periods
1. Transitional Arrangements for MDR/IVDR CE-Marked Devices
The new transitional arrangements for general medical devices, including custom-made devices, compliant with the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostics (IVDs) compliant with EU IVD Regulation (EU IVDR) can be placed on Great Britain market until either the expiry of the CE certificate or 30 June 2030 (whichever occurs first).
2. Transitional Arrangements for MDD/AIMD CE-Marked Devices
The new transitional arrangements for general medical devices compliant with the EU Medical Device Directive (EU MDD) or EU Active Implantable Medical Device Directive (AIMDD) with a valid declaration and CE marking can be placed on Great Britain market up until either the expiry of the certificate or 30 June 2028 (whichever occurs first).
3. Transitional Arrangements for IVDD CE-Marked Devices
The new transitional arrangements for IVDs compliant with the EU IVD Directive (IVDD) can be placed on the Great Britain market up until either the expiry of the certificate or 30 June 2030 (whichever occurs first).
This change will enable certain CE-marked medical devices to continue to be placed on the Great Britain market for substantially longer than previously planned. It is important to note that if placing medical devices on the Great Britain market under these transitional measures, device manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU as per the new amendment published by the EU Commission concerning the MDR). It is welcome news for device manufacturers given the ongoing development of UKCA regulatory requirements, as it avoids having to apply for both EU CE and UKCA certification for the duration of the new transitional periods.
However, 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. These devices can only be placed on the Great Britain market if the involvement of a Notified Body would be required under the EU MDR or IVDR (e.g. if it is an up-classified device or a reusable surgical instrument Class I device). Similarly, they will not include Custom-Made Devices (CMDs) compliant with EU MDD or EU AIMD as these devices can no longer be placed on the Great Britain market.
Where medical devices are subject to the requirements of any of the legislations cited above and, in order to be CE-marked, must also meet the relevant requirements of another piece of EU legislation (such as the Directive restricting the use of certain hazardous substances), they will still be able to be placed on the Great Britain market carrying a CE-mark to the above timelines—irrespective of whether the UK legislation governing the subject matter of that other piece of EU legislation would require a product to have a UKCA marking before that deadline. In order to maintain the use of the CE marking for a medical device in Great Britain, the manufacturer will need to meet all relevant EU legislation that governs their device.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD experts communicate with EU entities nearly every day and are the most experienced in the industry at accelerating regulatory submissions and approvals for manufacturers. Many of our Associates have previously held positions within these organizations, which provides Clients with the benefit of a more precise understanding of how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR and IVDR compliance planning, visit: https://namsa.com/services/regulatory-and-quality-consulting/.
We also invite you to access our complimentary MDR and IVDR Planning Resources, here.
Kevin Butcher is an experienced Senior Manager with extensive knowledge of medical device regulatory requirements, including Product Technical Files and QMS 3rd Party auditing. Mr. Butcher possesses 18 years of Notified Body experience, latterly as Certification Manager for SGS United Kingdom. Kevin joined the medical device consulting team at NAMSA in January 2021 and currently serves as a Principal Regulatory Consultant.