Medical device rules

Peraturan Alat Kesehatan

Balanced risk and benefits: the producer obligation to harmful substances in medical devices, and how complymarkets can simplify compliance

2017/745 Medical Device Regulation ("MDR") requires the regulation of substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) and/or endocrine disturbing substances in medical devices. This article provides a picture of the regulation for CMR substances and/or endocrine disturbing substances in the medical device, along with the producer obligations if the 0.1% threshold is exceeded.

The product in question:

Device, or part of the device, or material used in it, which:

  • Is invasive and directly in contact with the human body,
  • (Returning) giving drugs, body fluids, or other substances, including gas, to/destination/body, or
  • Transporting or storing drugs, body fluids, or substances, including gas, for (returning) given to the body.

Regulation:

  • Medical devices must not contain CMR substances and/or endocrine -disturbing substances in concentrations above 0.1% by weight per weight (W/W)/components.
  • Medical devices must not contain substances that are carcinogenic, mutagenic, or toxic to reproduction ('CMR'), category 1A or 1B, in accordance with Section 3 Appendix VI CLP Regulation (EC) No. 1272/2008, or substances determined as endocrine disturbing in accordance with Article 59 Reach Regulation (EC) No 1907/2

Producer Obligations:

If the threshold of 0.1% W/W is exceeded, the producer must:

  • Evaluate the benefits and include justification in technical files.
  • Marking the existence of the substance on the device itself and/or on the packaging for each unit or, if appropriate, on the sales packaging, with the list of substances.
  • Include instructions for use for groups of patients who are considered vulnerable to these substances.
  • Maintain Udi Online Database.

How complymarket can help you:

  • Complydoc:AWAN SOLUTION CODE INTELLIGENT AND FIRST SOURCE CODE FOR SUBSTMENT OF PASK CHAINS, PRODUCT MANAGEMENT MANAGEMENT & CHEMICALS TO Gather information from suppliers.
  • AD-HOC Consultation: The complymarket team has an extensive experience in providing regulatory support for the "MDR" medical device regulation.

Comments

Leave a comment or ask a question

I agree to the Terms of Service and Privacy Policy