Swissmedic Issues Deadline for Legacy Device Compliance

Swissmedic informed Swiss Authorized Representatives and Regulatory Importers of their expectations regarding follow-up on the transitional provisions and obligations related to legacy medical devices that comply with old legislation, with an important deadline approaching on September 26, 2024.

Key Highlights for the Swissmedic Legacy Device Deadline

Transitional Provisions:

• • These apply to devices compliant with old legislation and seeking certification under the EU-MDR.
  • The provisions allow legacy devices to be placed on the market until 2027 or 2028, provided regulatory requirements are met.

Verification and Due Diligence:

• • Authorized representatives and importers must verify and document the conformity of devices.
  • Evidence required includes a self-declaration by the manufacturer and a confirmation letter from the designated/notified body.

Non-Conforming Devices:

• • Devices that do not meet the transitional provisions cannot be placed on the market.
  • Importers and authorized representatives must ensure conformity before market placement.

No Feedback Required:

• • Economic operators are not required to provide feedback to Swissmedic but must ensure compliance.
  • Swissmedic can inspect devices on the market at any time.

You can download the English version of the letter that was sent by clicking here.

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If you need to speak to someone about the Swissmedic legacy device deadline, or need help getting your medical device or IVD compliant, contact us so we can assist you.

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative
  • Swiss Regulatory Importer
  • RA Consulting
  • QA Consulting