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Medical Device Regulation (MDR) Article 117 Assessment

Confirm that your drug-device combination medical products meet the requirements of MDR Article 117 with assessment services from SGS.

To gain EU market access, drug-device combination medical products need to meet MDR Article 117 requirements. As a Notified Body, we provide MDR Article 117 assessments and certification to verify the compliance of drug-device medical products, such as:

  • Pre-filled syringes
  • Pre-filled pens
  • Nebulizers pre-charged with a specific medicinal product
  • Patches for transdermal drug delivery
  • Pre-filled inhalers

Why choose MDR Article 117 assessment services from SGS?

We can help you to:

  • Ensure that your drug-device combination medical products meet MDR Article 117 requirements
  • Confirm that your device complies with the relevant General Safety and Performance Requirements (GSPR)
  • Gain a conformity assessment statement for inclusion in the Market Authorization Application (MAA)
  • Ensure free trade in EU markets

Why SGS?

We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

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