Swissmedic reorg adds new focus on medical device market surveillance
The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. AgencyIQ takes a look at what this could mean for medical device manufacturers.
Quick background on the medical device regulatory picture in Switzerland
- Switzerland follows E.U. device and IVD regulations but is not part of the European Union – or even the European Economic Area. After “ Swixit” and the failure to update the Mutual Recognition Agreement (MRA) with the E.U. in 2021, Switzerland became a third country from the E.U. perspective. This mean its Notified Bodies and Authorized Representatives were no longer recognized in Europe, so any manufacturers selling into both regions had to switch to a Notified Body recognized in Europe and add a second representative based in Europe. [Read a more complete summary of Swixit here.] Switzerland also couldn’t participate in the device database, EUDAMED, so it had to create its own – Swissdamed. But in order to maintain the security of its supply of devices and IVDs, Switzerland continues to recognize the validity of European Notified Bodies, EC certificates, and the CE mark. And it adapted its national laws to recognize the European medical device and IVD regulations (MDR and IVDR, respectively) by updating its medical device and IVD ordinances (MedDO and IvDO, respectively).
- In fact, Switzerland doesn’t approve devices on its own but instead relies entirely on the European CE mark. The Swiss Federal Council confirmed its intention to continue to follow European device regulations in mid-2022, even in the face of rising concern around the implementation of the European MDR. But as the MDR saga wore on, ultimately leading to an extension of the transition period from the old directive to the new regulations, Swiss MedTech (representing Swiss device companies) registered its concern with relying entirely on Europe for device approvals, ultimately leading Swiss Parliament to instruct the Federal Council to amend Swiss law to allow recognition of approvals by other trusted regulators, explicitly naming the U.S. FDA. To date, though, this law hasn’t yet been created and Switzerland currently still recognizes only the European CE mark.
Swissmedic oversees medical devices in Switzerland
- “ Swissmedic is the Swiss approval and supervisory authority for medicines and medical devices,” according to the organization’s homepage. “The institute ensures that only high-quality, safe and effective remedies are available in Switzerland – an important contribution to protecting the health of humans and animals.” A federal public institution affiliated with the Federal Department of the Interior, it oversees and operationalizes the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, or TPA).
- The TPA requires the Swissmedic Agency Council to create strategic objectives for approval by the Federal Council. The current approved objectives cover the years 2023 – 2026, laying out the regulator’s approach to surveillance, international cooperation, support of innovation, and how its activities will be funded. Recognizing rapid changes in science and technology in the device sector, Swissmedic is focusing on product innovation, the borderline between medicinal products and medical devices, and software products that may change after market launch. It plans to do this via international collaboration with other agencies and stronger surveillance of medical devices, especially in the face of a lack of a MRA with the E.U.
- Part of the strategic priorities are to increase supervisory and surveillance activities, so the regulator is increasing inspections of clinical trials, hospitals and other economic operators in the devices sector. Specific objectives for surveillance are increasing clinical trial inspections, moving from the current 5% to 20% but continuing with a risk-based approach. It is also increasing economic operator inspections.
- A Swiss device database: The Swissdamed database won’t be as extensive as the European version, EUDAMED – it won’t house information on clinical trials, vigilance reports or field safety corrective actions. However, it will include economic operator registration information and medical device and IVD information. [Read more about what the regulator plans for its database here.]
- More international collaboration: The regulator wants to increase participation in the International Medical Device Regulators Forum (IMDRF) and enable the free exchange of surveillance data with other regulators. Swissmedic currently is an official observer of the IMDRF, though it ultimately seeks to be a full member. The regulator had no international treaties with other regulators to exchange device data at the end of 2022, but is aiming to have three in place by the end of the strategic objective period.
- Finance: Swissmedic is financed through government payments, criminal enforcement, and procedural fees for medical device surveillance. Swissmedic reported a cash reserve of CHF 100 million, or about $118 million, at the end of 2022. The regulator plans to recover the costs of surveillance, funded by the federal government, with a target of 100%.
Swissmedic started 2024 with a reorganization to highlight its increased focus on medical device surveillance
- The reorganization creates a new Medical Devices Surveillance Sector, separated out from the Market Surveillance Sector to focus on surveillance and monitoring of medical devices. This is especially necessary in Switzerland, where the country currently relies solely on European device approvals and has no independent premarket review of its own.
- Responsibilities of the new sector will include clinical trial safety, vigilance and safety signals, and market monitoring, which were also the tasks of its predecessor, the Market Surveillance Sector. The sector will also oversee the use and processing of devices within hosptials. KAROLINE MATHYS is the head of the new sector.
- The reorganization separates device surveillance from medicinal product surveillance, which is divided into two sectors – licensing and surveillance, and product authorization and vigilance. Notably, the medicinal product authorization and vigilance sector has a new head – EVELINE TRACHSEL, taking over from CLAUS BOLT.
What does this mean for manufacturers?
- We have already started to see stepped-up enforcement. In 2022 and 2023, the regulator inspected a variety of medical device economic operators – CH-REPs, importers and class I medical device manufacturers – and found significant non-compliance, especially from the manufacturers. The new group is focused on surveillance, so we should see more resources in this area going forward.
- Does Swissmedic need to hire for the new department, and how might it finance any new positions? Given that it’s a new sector now separate from medicinal product vigilance and surveillance, it seems likely the group will need new specialists. In fact, of currently posted open positions, two of them are targeted specifically to medical devices, one a hospital inspector and the other a device inspector (both job descriptions in German). Notably, these aren’t new positions but have been up since October and November 2023, demonstrating the regulator’s intentions for the new group. One of the regulator’s objectives is to start using its large cash reserve, rather than focusing on building it up. As detailed above and per the 2022 annual report, the “vast majority of its income” comes from fees and levies, and only a small portion directly from the government funding.
- The introduction of the new sector may be preparing the market for other changes. Swiss Parliament voted in favor of a proposal introduced by Damien Müller in late 2022 that directs the Federal Council to amend Swiss law to recognize device approvals outside of Europe, explicitly including those from the U.S. FDA. While this has yet to occur and the new sector is directed more to device surveillance in the post-market space, it does set up a device-centric group that would be well-placed to expand in the future to include device market authorization.
- What of the MRA? Though the MRA lapsed in 2020 in the wake of Swixit, in the last few weeks, there has been some forward movement toward a new MRA. In mid-December 2023, the Swiss daily newspaper Neue Zürcher Zeitung (NZZ) reported (in German) on a Federal Council draft for a new negotiating mandate with the E.U. Five days later, the European Commission released a Question & Answer document on its proposal for a mandate to negotiate with Switzerland, based on the Common Understanding document that the Commission and Federal Council agreed to on December 15, 2023. After a successful negotiation and agreement, other bilateral agreements, including the MRA, would be able to be updated.
- The effect of a new MRA on other Swissmedic programs (foreign approval recognition, market surveillance) is unknown, but AgencyIQ will continue to watch that space. Presumably, a new MRA would at least obviate the need for the Swissdamed database, since the EUDAMED database is larger and more comprehensive and allows for stronger market surveillance though its vigilance and other modules.
Key Documents and Dates
- Latest News – New organizational structure with separate Medical Devices Surveillance Sector – Eveline Trachsel heads up the Medicinal Product Authorisation and Vigilance Sector, published January 3, 2024