Medical Device Regulations

balanced Risks and Benefits: Manufacturer Liability for Hazardous Substances in Medical Devices, and ComplyMarketHow to Simplify compliance

the European Union2017/745 Doctor Therapeutic Device Regulation ("MDR") ) requires carcinogenic, mutagenic, or toxic to reproduction in medical devices (CMR) and/ or dry Disturb endocrine substances to be regulated. This article provides an overview of CMR and/ or dry Endocrine substances and the manufacturer's liability if the > threshold exceeds

applicable product:

equipment or parts thereof or materials used therein, they:

• is invasive and in direct contact with the human body,
  
  
• (re) administer drugs, bodily fluids, or other substances, including gases, with / from the body,
  
  
• <span style="font-family: 'Microsoft JhengHei',sans-serif; mso-bidi-font-family: 'Microsoft JhengHei'; "> transfusion or storage of these drugs, bodily fluids or substances, including gases, for / re-(). given to the body.

>：

• DoctorThe device must not contain more than 0.1% weight/ weight(w/w) / components and/ or dry disturb endocrine substances.
  
  
• DoctorThe device must not contain > method according to CLP Gauge (EC) No. 1272/2008 with <span style="font-family: 'Microsoft JhengHei',sans-serif; mso-bidi-font-family: 'Microsoft JhengHei';">Recorded VI p. 31A or1B class of reproductively harmful, mutagenic or carcinogenic substances (‘CMR'), or according to REACH method(EC) No. 1907/2006 No. 59 and creatures the regulation of pesticide products (EU) No. 528/2012 No. 5(3)The stem disturb endocrine substances.

> manufacturer responsibility:

if super over 0.1%w/w thresholds, the manufacturer must:

• evaluate the pros and cons and justify the reasons in the technical documentation.
  
  
• in device itself and/ or each unit or, where appropriate, on the packaging for sale.
  
  
• if used for <span style="font-family: 'Microsoft JhengHei',sans-serif; mso-bidi-font-family: 'Microsoft JhengHei'; "> patient populations that are considered particularly vulnerable to these substances, including instructions for use.
  
  
• maintain UDI in Line database.

ComplyMarket can help you:

• ComplyDoC: is for smart IT for sustainability, chemical and product compliance management<span style="font-family: 'MS Gothic'; mso-bidi-font-family: 'MS Gothic';" > and the first open source generation code cloud solution to collect supplier information.
• ad hoc advisory: ComplyMarket team working on medical device regulation“MDR" provide method regulation support.