Interview with Karoline Mathys "The authorities now need to implement proactive surveillance for medical devices."

Dr. Mathys, why are new principles/regulations needed for medical devices?

The regulation of medical devices is a relatively recent phenomenon compared to the regulation of medicinal products. Medicines have been officially authorised and reviewed for over 120 years, compared to just 25 to 30 years for medical devices. As with any new regulation, what needs to be improved only becomes apparent in the practical application.

So where is action needed specifically?

The regulations introduced in Switzerland and the EU in the 1990s were not very detailed and were very largely based on the perception of the individual responsibility of the economic operators (manufacturers, importers, distributors, hospitals, etc.). It became apparent that the regulations had not been implemented uniformly across Europe and had a number of weak points. These had led to incidents and scandals with medical devices. The "Implant Files¹" were a case in point. The legislators therefore decided to flesh out and strengthen the regulations. In particular, the roles and tasks of the various economic operators were specified in detail, the requirements for official surveillance were tightened and more clinical evidence of the performance and safety of medical devices was demanded.

What is changing with the new regulations generally – and why are they better on the whole?

The main aim of the new regulatory system is to improve patient safety. This is to be achieved by increasing device safety and transparency. Specifically, clinical data on safety and efficacy, as well as on proof of performance, will now be required for all medical devices in higher risk classes, for example implants or surgical robots. The safety of devices will also need to be monitored continuously by the manufacturers and corresponding periodic update reports produced. The tasks of the other operators, such as importers, authorised representatives for manufacturers from third countries, distributors, etc., have also been specified in greater detail. They will all be involved in device surveillance.

"The range of medical devices will continue to expand."

What does that mean in practical terms?

The requirements for the notified bodies (con­formity assessment bodies) have been tightened considerably. For all devices that are not in the lowest risk class (Class 1), these notified bodies must be consulted for the purposes of market access. The authorities are responsible for designating and monitoring these bodies. This process includes several audits with international teams of inspectors and numerous reports issued by the notified body and the competent authority. This can take several years. In addition, the authorities now need to ensure proactive surveillance.

What about the issue of transparency?

For the purposes of implementation in the EU, the comprehensive central EU database, EUDAMED 3, will receive all the relevant information and allow the authorities to cooperate with each other. Some of this information, for example on the economic operators and later on the devices, will be made public.

In future, medical devices must be clearly identified by means of a "Unique Device Identifier" (UDI), which will improve traceability and surveillance.

How did you prepare for the Federal Council's decision on the Framework Agreement – did you have a Plan A and Plan B at the time?

The Federal Council has clearly decided that Switzerland wants the same level of safety as and regulation equivalent to that in the EU. Accordingly, the focus has been on preparing for implementation in cooperation with the EU partner authorities. However, Swissmedic had to consider the worst-case scenario from the outset, i.e. the absence or delayed updating of the bilateral agreements (MRA). We have therefore set up our processes so that Swissmedic is able, as far as possible, to continue its surveillance activities without a direct connection to the new central EU database. For example, by managing the processes and monitoring data from Switzerland in our own information system.

To what extent are we dependent on the EU Medical Devices Regulation (MDR)?

The Swiss regulation is very largely based on the EU regulation in order to prevent differing requirements being defined for industry and to achieve an equivalent safety standard for Swiss patients.

What specific collaborations are planned with the European authority?

Until 26 May 2021, Switzerland was part of the EU single market and Swissmedic was a partner on equal terms in the network of authorities and closely involved in the joint surveillance activities. As a result of the breakdown in the negotiations on the Framework Agreement, the EU has refused to update the bilateral agreements on medical devices, which was needed in order to continue this cooperation. The EU equates the Swiss situation with Brexit and unilaterally considers the bilateral agreements on medical devices to be no longer applicable.

What are the consequences for Switzerland?

Since 26 May 2021, the agreement-based framework for continuing the collaboration has been jeopardised by the EU, particularly as regards the sharing of information and data between the EU partner authorities and Swissmedic. We no longer have access to relevant EU databases used by the executive authorities, and we have been actively excluded from the network of authorities. This mainly affects the acquisition of relevant infor­mation such as inspection reports of foreign manufacturers or notified bodies, official safety reports, etc.

What additional tasks (within Swissmedic) have resulted from this new set-up?

The monitoring workload is increasing due to the lack of collaboration and work-sharing with the partner authorities. Procuring information in the event of incidents is now more time-consuming, and the lack of information from authorities means that Swissmedic is unable to identify device deficiencies at an early stage.

How can Swissmedic position itself and what opportunities will emerge?

Swissmedic is able to rely on highly competent and experienced staff and will now be involved in global forums in the context of regulatory cooperation. Specifically, to keep abreast of regulatory developments we will be involved in the International Medical Device Regulatory Forum (IMDRF). A realignment of the operational cooperation in surveillance requires corresponding agreements for sharing information and data and will therefore only be possible in the medium term.

Why is the role of Swissmedic so important when it comes to medical devices: Are there parallels with medicinal products?

Since medical devices are not officially authorised, Swissmedic focuses on their market surveillance. Healthcare professionals, but also economic operators, are legally obliged to notify Swissmedic of ­serious incidents involving medical devices – and they also have to report required corrective actions, for example a product recall. Swissmedic reviews the proposed actions, publishes companies' safety reports and monitors their implementation in Switzerland. If necessary Swissmedic orders further measures. Swissmedic also checks the conformity of devices on the market following corresponding reports or through concerted campaigns.

What about security of supply?

Since, as of the end of May, Switzerland is now classed as a third country by the EU in relation to medical devices, there are negative consequences both for trade and the monitoring of device safety. In order to maintain an orderly supply here, Switzerland will unilaterally recognise certificates issued in the EU. For the appointment of an authorised representative for manufacturers in the EU, required for safety purposes, the Federal Council has defined fairly long transitional periods designed to enable processes to be adapted and suppliers to be changed.

What do you think medical devices will look like in the future?

The range of medical devices will continue to expand. Increasingly there will be complex products with interoperable software components, and the number of combination products, i.e. medicinal products with a medical device component or medical devices with a medicinal product component, will continue to grow. In addition to the classical medical devices, there will be a lot more complex devices such as surgical robots, analytical tools or wearables such as smartwatches for measuring medical parameters.