Trelleborg Supports Customers in Meeting New Medical Device Regulation
Trelleborg Healthcare & Medical supports its customers in meeting the EU Regulation on Medical Devices 2017/745 (MDR), which was issued on 5 April 2017 and will fully apply in EU Member States from 26 May 2020.
The regulation applies to medical devices, which means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by a manufacturer to be used, alone or in combination, for human beings, including borderline products.
Meeting MDR requirements
Andreas Schmiedel, Technical Manager at Trelleborg Healthcare & Medical Europe, says: “We are aware of the requirements coming out of MDR with regard to our materials used in medical devices.
“To this end, we have performed extensive testing to prove that our materials meet the stringent requirements of the new regulation applicable to these applications. Meeting it is challenging, as the regulation means complying with other standards that are applicable to the application, such as ISO 10993.
“In all cases, meeting the regulation is not simply about testing the materials, but also needs detailed knowledge of an application as testing parameters have to be derived from the application and a risk assessment of that application as it relates to MDR. Compliance can only be achieved through very careful and close cooperation with all involved parties.
“This is part of Trelleborg Healthcare & Medical’s offering to its customers, working in partnership we support with our materials’ expertise to ensure the components that we supply will facilitate compliance to the very demanding new MDR and mitigate risk to the highest extent.”
Attention on complying to MDR was on nanomaterials, carcinogenic, mutagenic or toxic (CMR) substances, endocrine disruptors and phthalates.
Testing involved investment in advanced analytical instrumentation including a coupled GC-MS (gas chromatography – mass spectrometry) for migration studies that were conducted in worst case scenarios. Any substances identified were then checked against MDR requirements to provide all the information necessary to customers to support in making their medical device compliant to EU Regulation on Medical Devices 2017/745, as well as other relevant regulations and standards.