Medical device & Regulatory Affairs
Medical device & Regulatory affairs
Medical device compliance
Market access for medical device is subject to strict regulation to ensure the reliability and security of the devices and patient safety. 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 regulations require manufacturers to build a market access dossier based on international standards (ISO and EN) and to adopt a strategy for your market segment.
Where the law requires an authorization from an authority, get CE marking and submission to a notified body, you might also need to proceed to clinical trials with submission and approval from an ethics committee. Also, manufacturers shall implement a post-market surveillance program (materiovigilance system) for managing (serious) adverse events. Authorities have enforcement powers and may conduct audits and investigations (Swissmedic for Switzerland).
Qualification & classification as medical device
Does your product meet the definition of a medical device? Are you sure about the classification of your product in accordance with the legislation? We provide advice on marketing and advertising of your products to remain compliant, which includes hardware and software, such as mobile health applications (decision support software). Our lawyers help you decide about your best strategy depending on the qualification and classification of your products.
Stronger Regulation in the EU (MDR | IVDR)
With Regulation EU 2017/745 (on medical device) and Regulation 2017/746 (in vitro diagnostic), the tight deadline for compliance by 26 May 2020, creates hard constraints for manufacturers and other stakeholders in the medtech sector. For some companies, compliance means running out of business or onerous measures and actions for compliance and maintain products on the market. We guide you to prepare for compliance and decide on a risk-based strategy in Switzerland and with our partners abroad.
Litigation & Swissmedic
Our firm advises you for market access and dealing with authorities in Switzerland. European standards impose you strict obligations for remaining compliant with the EU and Swiss legislation. Our lawyers will counsel and defend you in the event of any administrative or criminal procedures initiated by Swissmedic related to your products.