Breach of risk and profit: The duties of the manufacturer for risky substances in medical devices and how complimate compatible compliance can simplify the compliance
Medical device regulation (EU) 2017/745 ("MDR")Cancer in medical devices,Toxic for mutagenic or breeding (CMR)And/or there is a need to monitor the endocrine-ficular substances. This article in medical deviceCMRAnd/or provides the directory for endocrine-fifth substances,And if the manufacturer's responsibilities0.1%If the limit is crossed.
Product Scope:
Device,Or their parts or materials used in them,Who:
- humanThey come in direct contact with the body and are invaders,
- ,Again) medicines,Physical liquid,This includes gas,K/to body,Or
- These types of medicines,Physical liquid,Which contains gas,To manage or store (again),
Methods:
- MedicalDevice0.1%Weight weight (weight (w/w)/The component should not include CMR and/or endocrine-metamorphic materials.
- Medical deviceClpRegulation (EC) No 1272/2008SequenceViPart of3Category according to1AOr1bCancerogenic according to,Toxic for mutagenic or breeding ('CMR')To substances,OrReachRegulation (EC) No 1907/2006And lifestyle product regulation (EU) No 528/2012The substances defined according to should not include.
Manufacturer's responsibilities:
If0.1% w/wThe border is crossed,So the manufacturer has to do the following:
- Benefit-Cost evaluation and establish justice in the technical file.
- Equipment on its own and/or on the packaging of each unit or,When it is suitable,Labeling the presence of such substances on self -packaging with a list of such substances on sales packaging.
- Include instructions for use for patient groups considered particularly sensitive to this type of substances.
- UdiMaintaining online database.
HowComplymarketCan help you:
- Complydoc,A wise IT and Supply Chain Sthace,The first open source code for chemical and product compliance is the cloud solution that can be helpful from supplies to collect information from your superior.
- Ed-Hawk Advice:ComplymarketTeam medical device regulation "MDR "There is a lot of experience in providing legal support for.