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07.05.2024   |   Vienna, Austria

Our sempercare® sterile examination gloves are MDR-ready!

Discover safety and versatility with our sempercare® line, now fully compliant with the Medical Device Regulation (EU) 2017/745. From wound care to trauma treatment, our gloves are a trusted choice in critical medical applications, backed by our commitment to stringent regulatory standards. We are pleased to announce that our  our sempercare® velvet sterile, sempercare® nitrile sterile, and sempercare® edition IC sterile gloves are  meeting the standards of MDR compliant. You thus may find the already updated Declarations of Conformity here.

In reflection of this compliance, our labeling undergoes these adjustments:

  • Every mention of the Medical Device Directive has been updated to ensure compliance with the Medical Device Regulation.

Previously the product was marked as "MEDICAL 93/42/EEC Class Is", which is compliant with MD Directive 93/42/EEC.

Now the update shows that the compliant with MD Regulation (EU) 2017/745 information.

  • Embracing MDR Annex I Section 23.2. q), our labeling identifies the product as a medical device, featuring the relevant symbol (EN ISO 15223-1).
  • Additionally, in line with ISO 11607-1, our sterile barrier system is clearly highlighted with the corresponding symbol on the label (EN ISO 15223-1).

All new orders of these products will be delivered under the MDR. Please contact your Area Sales Manager if you have any questions or would like to place an order.

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