Medical Device Regulation

Balance of risk and benefit: manufacturer's duties to risky substances in a medical device and how CompleMarket can simplify compatible compliance

Medical Device Regulation (EU) 2017/745 ("MDR") , mutagenic or toxic to reproduction (CMR) and/or need to monitor endocrine-toxic substances. This article provides directory for CMR and/or endocrine-deleticular substances, And if 0.1% limit is exceeded.

Product Scope:

device, or their parts or the materials used in them, which:

• human come in direct contact with the body and are invaders,
  
• (re)medicines, bodily fluid or Other substances, contains gases, to/se body, or
  
• this type of drugs, physical fluid or substance, which includes gas, To manage or archive (re),

methods:

• medical device 0.1% weight by weight (w/w)/The component should not contain CMR and/or endocrine-deleting substances.
  
• medical device CLP regulation( EC) No 1272/2008 Part 3 or 1B According to Carcinogenic, mutagenic or toxic to reproduction ('CMR') to substances, or REACH regulation (EC) No 1907/2006 and bacteriomatic products regulation (EU) No 528/2012.

Manufacturer's Responsibilities:

if 0.1% w/w crosses the limit, So the manufacturer must do the following:

• labh-do a risk assessment and establish justice in the technical file.
  
• On the appliance itself and/or on the packaging of each unit or, When it is appropriate, Labeling the presence of such substances on own packaging along with a list of such substances on sale packaging.
  
• Include instructions for use for patient groups considered particularly sensitive to these types of substances.
  
• UDI maintaining online databases.

how ComplyMarket Can help you:

• ComplyDoC: An intelligent IT and supply chain sustainability, is the first open source code cloud solution for chemical and product compliance that can be helpful for collecting information from suppliers to your super.
  
• ad-hoc advice: ComplyMarket team The medical device regulation "MDR" have much experience in providing legal support for.