Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?

Question

We want to certify our software as a medical device in the EU and Switzerland. I have two questions:
• Is it necessary to first obtain ISO 13485 certification before applying for CE marking? What are the advantages of this approach compared to going directly for CE marking?
• If we are certified in the EU, are we also compliant in Switzerland? We are based in Switzerland.

Dr. Oliver Eidel · Accepted Answer

For your first question: MDR requires manufacturers to establish a QMS (Quality Management System), as stated in Article 10 MDR. For class IIa devices and above, this QMS will be assessed as part of the conformity assessment. For class I devices, an external assessment or certification is not required. In general, ISO 13485 certification is not mandatory, but your QMS will be evaluated as part of the conformity assessment regardless of ISO certification. Many companies choose to get ISO 13485 certification first as a kind of 'final rehearsal'—if you fail, it has no regulatory consequences and can help you prepare for the real conformity assessment.
For your second question: If you are based in Switzerland and want to place a CE-marked device on the EU market, you must appoint an EU Authorized Representative immediately; there is no transition period. The EU AR helps register your device in the local Competent Authority’s database. While Switzerland recognizes CE marking, you still need to register your device with Swissmedic and meet local requirements for vigilance reporting. The Swiss MepV is nearly identical to MDR, but local obligations still apply.
One extra note: Be sure to observe the required languages in Switzerland.

Answer

One of the requirements for CE marking, depending on your device classification, is to have a certified QMS in place. So, while ISO 13485 isn’t always required, something equivalent is needed for the CE process.

Answer

If you’re located in the EU but want to sell in Switzerland, you will need a Swiss Representative since the mutual recognition agreement isn’t in place. There are some deadlines, but you should check the latest for your device category.

Answer

There’s some ongoing discussion about whether standalone software (that isn’t distributed on a physical data carrier) needs an importer in Switzerland, but regardless, you still need to register with Swissmedic and meet Swiss vigilance requirements.

Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?

4 Answers

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