“On a duly justified request, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of which is in the interests of public health or patient safety or health.”
(Art. 22(1) MedDO)
We are proud to share a recent success story: MDSS CH GmbH has successfully obtained a derogation authorisation from Swissmedic as a Swiss Authorised Representative (CH-REP) for a medical device.
By sharing this case, our goal is to raise awareness among manufacturers that critical situations — such as relevant conformity assessment or incomplete IFU translations (Art. 22(1) MedDO) — may qualify for a derogation authorisation from the authority. This mechanism ensures that patients continue to receive vital treatments without interruption.
In this case, the manufacturer lost their EC Certificate due to the well-known challenges of the MDR transition. Despite the bureaucracy behind the certificate loss, the manufacturer still had to undergo extensive documentation and justification steps to demonstrate that the device could legally be placed on the market.
From our experience, we would like to highlight the exceptional cooperation of the authority and share a few key factors for a successful derogation application:
🔹 Clinical benefit and criticality of the device in patient care are central to the justification.
🔹 The authority will request comprehensive market research, including competitor information and available alternatives.
🔹 A clear and concise explanation of why the device is irreplaceable — even if alternatives exist — forms the backbone of the dossier.
🔹 Expect multiple rounds of clarification from the authority — these ensure that the decision is well-founded and robust.
🔹 Only patient benefit is an acceptable justification. Financial or commercial arguments are not considered if valid alternatives exist.
🔹 A statement from the treating hospital confirming the urgent need for the device can significantly strengthen the application, supporting the justification that placing the device on the market serves public health or patient safety.
If your device finds itself in a similar situation, know that there are solutions.
The MDSS team has extensive experience supporting manufacturers with derogation requests — both in Switzerland and the EU. While Switzerland has its own process, MDSS has also successfully managed numerous applications under Article 59 and Article 97 MDR for legacy devices prior to Regulation (EU) 2023/607.
👉 Whatever regulatory challenges come your way — MDSS stands by your side.
📨 Reach out to us to learn how we can support your derogation application.
