Medical Device & Regulatory Affairs

Medical device & Regulatory Affairs

Medical device & Regulatory affairs

Medical device compliance

Market access for a medical device is subject to strict regulation to ensure the reliability and safety of the device and the protection of patients. Depending on the classification based on the degree of risk for the human body (class I, IIa, IIb or III), EU and Swiss medical device rules require manufacturers to build a market access dossier based on international standards (ISO and EN) and to adopt a strategy for their market segment.

Where the law requires an authorisation, CE marking and submission to a notified body may be needed, and you might also have to run clinical trials with submission to and approval from an ethics committee. Manufacturers must also implement a post-market surveillance programme (materiovigilance system) to manage serious adverse events. Authorities have enforcement powers and may conduct audits and investigations (Swissmedic for Switzerland).

Qualification & classification as a medical device

Does your product meet the definition of a medical device? Are you sure about its classification under the applicable law? We advise on the marketing and advertising of your products so that you remain compliant, for both hardware and software, including mobile health applications and decision support software. Our lawyers help you decide on the right strategy depending on the qualification and classification of your products.

Current EU framework (MDR | IVDR)

The Regulation EU 2017/745 (on medical devices) and the Regulation 2017/746 (in vitro diagnostics) are fully applicable. Regulation (EU) 2023/607 extended the transition periods, subject to conditions: an application lodged with an MDR-designated notified body before 26 May 2024, and a quality management system and a written agreement signed with that body before 26 September 2024. The main deadlines are now 31 December 2027 for class III and implantable class IIb devices, and 31 December 2028 for other class IIb, class IIa and class I sterile, measuring or reusable surgical devices. We help you build a risk-based strategy, in Switzerland and abroad, with our partners.

Switzerland as a third country

In the absence of an updated Mutual Recognition Agreement with the European Union, Switzerland has been treated as a third country since 26 May 2021. Foreign manufacturers placing a device on the Swiss market must appoint a Swiss Authorised Representative (CH-REP) and obtain a Swiss Single Registration Number (CHRN) in Swissmedic’s swissdamed database. Conversely, a Swiss manufacturer targeting the EU market must appoint an EU authorised representative (EC-REP). A revised agreement was signed on 2 March 2026 but is not yet in force: until it is ratified, this regime remains unchanged.

Litigation & Swissmedic

Our firm advises you on market access and on dealings with the authorities in Switzerland. European standards impose strict obligations to remain compliant with EU and Swiss law. Our lawyers advise and defend you in any administrative or criminal proceedings initiated by Swissmedic in relation to your products.

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Our services

We offer the following services and work with our partners on:

Medical devices and regulatory affairs: legal and regulatory advice, qualification and classification, Swiss Therapeutics Act, Medical Device Ordinance and European Medical Device Regulation (MDR) to prepare for 26 May 2020.
Market access & post-market surveillance; dialogues with authorities, CE marking, notification and authorization from authorities, submission of your dossier to Swissmedic, ethics committees, clinical studies of medical devices.
Patient support programs: counselling and providing guidance to HCPs, HCOs, patient advocacy organizations, programs using technologies and innovative solutions for patients.
Data Privacy & GDPR: advice on data protection, privacy by design, GDPR, e-Marketing, how to advertise in the context of healthcare, for mobile health and connected medical device in the healthcare sector.
Digital & mobile health: software as a medical device (SaMD), mobile applications (Apps) eHealth, telemedicine, use of technologies in hospitals, private clinics, insurances, start-ups, medtech and pharmaceutical companies.
Intellectual Property, Contracts and Terms & Conditions
Training and conferences: on medical device, regulatory compliance and digital health.

Practical examples

Does my product / App meet the definition of a medical device

We analyse your products, whether hardware medical device or software, including mobile applications and counsel you on the marketing strategy, qualification and classification of your device or medical Apps (health Apps). If you do not intend to sell a product as a medical device, you should review your marketing strategy to ensure you do not fall into the qualification of medical device. This would trigger huge costs to comply the MDR / IVDR or the Swiss legislation.

If your product or your solution is qualified as a medical device, you will have to comply with the regulatory requirements for medical devices (MDR – EU | ODim – CH).

Litigation against Swissmedic

We assist and defend you in any proceedings against Swissmedic in the event of a refusal, suspension or prohibition of your device to be on the market, or in the event of post-market surveillance.

We also advise you on the qualification and classification of medical devices in the event of administrative or criminal litigation against authorities.

Data protection laws, GDPR compliance for medtech

Data protection, privacy and security is a big piece of life sciences and has become more and more complex. All stakeholders have a word to say on data privacy, including clinical study sites, Ethics Committees, health authorities, companies and regulators.

We help you navigate through this complex environment to:

chose the right legal basis,
identify the roles and responsibilities of the parties in a contract (controllers, processors and joint controllers)
draft appropriate data privacy agreements,
implementing data protection policies and a comprehensive data protection programme for data management in full compliance with data privacy laws around the world, including the Swiss Federal Data Protection Act (DPA) and the General Data Protection Regulation (GDPR).

We write and offer you documentation for your products, mobile applications and healthcare software, on smartphones, telemedicine platforms in your industry.

Clinical research (R&D) and patient support programs

Hospitals and life sciences companies can initiate research projects, market research or even collaborate on projects involving cloud computing, network solutions with patient organizations or other patient advocacy institutions or organizations.

Research. We advise research and development centers using software and digital health technologies to ensure compliance while conducting research projects.

Patient support programs. The use of mobile applications and medical software as part of patient support programs to enable follow-up of patient’s disease and treatment in conjunction with their physician.

We advise pharmaceutical, medical device, cosmetics and technology companies, and healthcare institutions (HCI) in research projects and the development of patient support programs.

Training on medical device and digital health

We train health professionals, researchers and entrepreneurs in e-health, software and health issues, and medical device regulation.

Medical Device & Regulatory Affairs

Medical device & Regulatory Affairs