Below is an overview of the September news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., EMDN Working Group Plans and the latest on Swiss Parliament’s decision to allow FDA devices onto the market.

EU Updates

Class D Transition Period Clarifications

MDCG 2021-4 rev.1, on transitional provisions for Class D IVDs was updated. It is available: HERE

The following changes were made: obsoleted Q1; minor revisions and editorial changes to some of the questions; larger revision to Q6 on EURLs; new question added – “What does the date of application on the designation of EURLs (1 October 2024) mean in practical terms for EURL tasks, and in particular for sample or batch testing according to Article 100(2)(b) IVDR and performance verification according to Article 100(2)(a)?”

UDI-DI for Spectacle Frames, Lenses and Ready-made Reading Glasses

The European Commission will launch a new ‘Have your say’ initiative in Q1 2025: HERE

It is to allow spectacle frames, lenses, and ready-made reading glasses manufacturers to utilize a Master UDI-DI.

The purpose of the Master UDI-DI is to group devices that have a high level of individualization, to help reduce the number of entries made into the EUDAMED device registration module.

Health Technology Assessment (HTA) Regulation

The rolling implementation plan for Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) has been updated: HERE

While not specifically related to MDR CE Marking compliance, the HTA Regulation helps standardize the clinical assessment of new health technologies (primarily medicines and certain high-risk medical devices), to inform reimbursement decisions.

The regulation establishes a framework for Joint Scientific Consultations (JSCs). JSCs can advise on the clinical evidence needed to demonstrate value from a health technology assessment and reimbursement perspective. While manufacturers still need to work with their Notified Body on clinical evidence for CE Marking, the introduction of JSCs helps manufacturers better align their clinical evidence to include both regulatory and reimbursement expectations, from the start.

UK Updates

Status of the MHRA’s 2024 Roadmap

The MHRA blog was updated on 25 September 2024 with updates on regulatory initiatives: HERE

Post-market Surveillance (PMS) Legislation

The PMS requirements will be presented to Parliament by the end of this year, followed by a six-month transition period.

“It remains the plan to bring our Medical Devices 2002 regulations up to date through a series of statutory instruments (SI), beginning with one that sets out clearer rules for Post Market Surveillance (PMS).

PMS covers the actions manufacturers need to take to monitor and report on devices once they are on the market. We have been working hard since May 2024, when we originally planned to put this to MPs and Peers, to make sure we minimise any delays, and I was really happy to see that Baroness Merron chose to announce last week that the government intends to lay the PMS regulation in Parliament before the end of the year.”

Proposed Pre-market Legislation

Plans for new statutory instruments (SI), which will introduce requirements such as the following:

“…the measures to improve patient safety will include:

• Increasing the classification and therefore the level of scrutiny of some medical devices.
• Introducing a legal requirement for UDIs, in line with international best practice, allowing devices to be identified within the supply chain and making it easier to identify products that may be impacted where there is a concern about product safety.
• Implant cards – Patients should know exactly what has been implanted into them, both to enable them to give informed consent but also to know when any safety alert or concern impacts on them. In the new regulations we intend to add a requirement for manufacturers of implantable medical devices to provide cards to be given to patients, in line with requirements already in force in the EU.
• Claims – A key part of regulatory approval is the statement a manufacturer makes about the intended purpose of the device. If the device is used for any other purpose that would be outside the regulatory approval. In the new regulations we plan to introduce new rules on what can be claimed publicly about a device to ensure it is consistent with the purpose the device has been approved for.”

International Recognition Framework

Watch for a public consultation on the proposal soon:

“We already allow products approved in the EU on to the GB market and this will continue, in line with EU transition provisions, until at least 2028 (2030 for some products). In May 2024, we published draft proposals for longer term international reliance and recognition from a wider range of countries. Since then, we have worked with volunteer companies in a sandbox type way, to develop the framework using example products of different types and from different sectors. This has enabled us to develop more detailed proposals for a focused public consultation in 2024.”

Open Position

The MHRA is looking for a new ‘Head of Software and AI’ as a medical device. The positing is available: HERE

AI Airlock Program

The MHRA is asking applicants to join the AI Airlock pilot program, which is the “MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products”. The intent of the program is to use real-world products to help guide future guidance and policy.

“This application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock pilot. We are looking to recruit 4-6 candidates to form the pilot cohort that cover a wide range of regulatory issues, healthcare or clinical disciplines and levels of product and regulatory development.

During the Airlock programme candidates will benefit from a unique collaboration of industry and regulatory experts, a bespoke testing plan and gain an improved understanding of the current regulatory framework. Participation in the regulatory sandbox presents an opportunity for a proactive approach to AIaMD regulation, derisk the innovative products ahead of entering the market and may benefit future routes to market.”

The application window is from September 23, 2024 – October 7, 2024, and the project will run until April 2025.

The application is available: HERE

Swiss Updates

Notice Regarding Legacy Device Status

Swissmedic issued a statement to Swiss Importers and Authorized Representatives: HERE

It advises they must verify that manufacturers of MDD/AIMDD legacy devices have met the September 26, 2024, deadline. i.e., that the manufacturer has a signed agreement with a Notified Body for MDR CE Marking.

They highlight that if the manufacturer has not complied with this requirement, then 1) importers may not place that device on the Swiss market and 2) authorized representatives must take necessary measures, including terminating the mandate with the manufacturer if required.   

Certificates of Free Sale Guidance

Swissmedic updated its guidance document on Certificates of Free Sale: HERE

It now includes a requirement to provide verification that the manufacturer has met the September 26, 2024 deadline, to have a signed MDR agreement in place with a notified body.