Below is an overview of the August news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, such as the public consultation for new IVDR common specifications, the survey to collect feedback on e-IFUs for medical devices, and more.

UK MHRA Free Increase: Open Consultation

The MHRA is considering two fee changes for medical devices, under Proposal 2 and Proposal 3: HERE

Proposal 2 – Annual Registration Fee

Currently, the MHRA only charges a fee during the initial device registration process. However, they are now proposing to collect an annual registration maintenance fee, to help cover their ongoing post-market activities.

The suggested fee is £210 per GMDN code.

The MHRA included a table assessing the impact across all registered devices. A large number of companies are shown to have only one GMDN code registered. However, the cost can become significant for companies with a high volume of devices. For example, if a manufacturer has 100 GMDN codes registered, they can expect to pay £21,000 per year.

How will fees be collected? The proposal states:

“It is intended that the MHRA registration system, with some modification, will automate the initial registration charge and its annual renewal.”

Proposal 3 – Regulatory Advice Meetings

The MHRA intends to launch a new service providing “expert regulatory advice to medical device manufacturers”. It is intended particularly for “novel and/or complex products with the potential to significantly improve patient outcomes, where the application of the Regulations is not straightforward and easily understood”.

The MHRA acknowledges that they already provide this type of support at no cost; however, charging a fee would allow more resources to be made available.

The proposed fee is:

“… £987 for a one hour meeting. This is based on the cost of internal MHRA discussions, meeting preparation, the meeting and any post meeting feedback.”

Timing

The MHRA is aiming to implement the new fee structure in April 2025.

Provide Your Feedback

The survey will run from 29 August 2024 to 24 October 2024. The link to participate is: HERE

GMDN Agency White Paper

The GMDN Agency published a white paper titled “Medical Device Nomenclature – What next Globally?”: HERE

As noted here, in 2023 the GMDN Agency conducted a feasibility study on mapping GMDN codes to EMDN codes. In it, they outline the differences between the two systems, and the inherent difficulty in directly mapping codes.

This update provides more detail around mapping concerns and a table of the main differences between GMDN, EMDN, UNSPSC, and UMDNS codes (page 5).

The report concludes:

“The most viable solution, outside of a universally adopted nomenclature, would be a mapping between the nomenclatures to support information exchange. With the different features of the nomenclatures discussed above, mapping becomes a huge challenge for which the resources are not readily available. Continuous development, validation, and maintenance of the map would have significant associated costs with no clear industry steer on how this would be funded or who would manage the ownership of the mapping.”

In other words, for now and the foreseeable future, manufacturers must still individually identify applicable GMDN vs EMDN codes for their devices.

Europe Updates

UDI Issuing Agencies

Commission Implementing Decision (EU) 2024/2120 renews the designation of the four UDI issuing agencies for a further five years: HERE

As a reminder, the agencies authorized under the MDR/IVDR are identified in Commission Implementing Decision (EU) 2019/939. They are:

1. GS1 AISBL
2. Health Industry Business Communications Council (HIBCC)
3. ICCBBA
4. Informationsstelle für Arzneispezialitäten — IFA GmbH

EUDAMED: New Videos Published

One is for the general public, explaining what it is and why EUDAMED important for EU medical device compliance: HERE

One is for the ‘restricted’ site, i.e., the site used by economic operators to register their companies and devices. This video highlights the mandatory use of EUDAMED and provides a high-level overview of the modules and steps: HERE

Switzerland Updates

‘swissdamed’ Registration Database

‘swissdamed’ went live on August 6, 2024; the confirmation is available: HERE

As reported previously, no action is required for non-Swiss manufacturers. However, Swiss-based economic operators should have received a letter from Swissmedic by now, to verify their information was rolled into the new system correctly.

3D Printers

Swissmedic published an information sheet on 3D printers: HERE

It is targeted “…for manufacturers and users of medical devices, who use 3D printing technology. It provides guidance on the most relevant applicable legal bases.”

Supply Shortages and…

Whatever happened to Swiss Parliament’s vote to allow FDA products on the market?

Swiss MedTech linked to a short news video, in which Damian Müller, the President of Swiss MedTech, was interviewed: HERE

The video is in German, but in summary: due to the increased cost and time to CE Mark under the MDR, Switzerland is facing medical device supply concerns.

As a result, Swiss MedTech continues to lobby for FDA devices to be allowed on the Swiss market. The proposal successfully passed through Parliament in November 2022. However, despite the vote, there has been no discernable movement. The Swiss Federal Council advised they did not believe this action was warranted and would reassess at a later date. Presumably, they are first waiting to see if the new EU-Swiss negotiations will be successful — their main priority being to reenter the European Single Market. Then, depending on if the negotiations are successful or not, assessing if and when FDA devices may be granted access to the Swiss market.