Background

Due to the lapsed Mutual Recognition Agreement (MRA) between Switzerland and Europe, Switzerland is a ‘third country’ for medical devices. Therefore, since May 26, 2021 (medical devices) and May 26, 2022 (IVDs), Switzerland has had a separate regulatory framework.

Despite the lapsed MRA, Swissmedic has kept its vigilance requirements mostly aligned to Europe’s. Examples of differences include:

• The Swiss Authorized Representative must be copied on all vigilance communication between the manufacturer and Swissmedic.
• System/Procedure Pack Producers (SPPPs) are required to report vigilance and field safety corrective actions (FSCAs) that occur in Switzerland.

“The completed [MIR] form should be sent to [email protected]. If the report is not submitted by the Swiss authorised representative, the representative should be included in the e-mail distribution list.”

“To report an FSCA to Swissmedic, complete the following form in English or one of the Swiss national languages and send it electronically and in machine-readable format to [email protected]. Manufacturers or SPPPs not based in Switzerland or Liechtenstein must include the authorised representative in the mailing list…”

MIR Form and Guidance

Swissmedic has updated its MIR form to align with the EU’s new MIR Form v7.3.1. Further, it has published an updated guidance on how to complete the MIR form to meet Swiss requirements.

Both forms are located: HERE

MIR Form: Scroll down to document “MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1”

Guidance: Scroll down to document “MU680_20_815e_WL_Guidance document CH Guide Manufacturer Incident Report (MIR)”