Trelleborg’s healthcare & medical operation is supporting 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.
Andreas Schmiedel, Technical Manager at Trelleborg’s healthcare & medical operation in Europe, says: “We are aware of the requirements coming out of MDR with regard to our materials used in medical devices. Trelleborg’s focus on helping our customers bring products to market faster and on ensuring consistent, reliable supply and the highest quality For that we’ve invested significant time and effort in understanding Europe’s latest changes to MDR.
“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.
“This is not simply about testing the materials. According to MDR, test parameters should be based on detailed knowledge of the medical device, application and a risk assessment. Compliance can only be achieved through very careful and close cooperation with all parties involved in the development of a medical device.
“This is part of Trelleborg’s healthcare & medical 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.
For further information on Trelleborg Healthcare and Medical go to tss.trelleborg.com/healthcare
For more information, please contact:
Tel: +49 711 7864 8115
About Trelleborg Healthcare & Medical and Trelleborg Group
Trelleborg Healthcare & Medical helps pharmaceutical and medical device companies improve patient quality of life. It does this by forming lasting partnerships with customers to develop innovative, reliable engineered polymer solutions for demanding medical, biotech and pharmaceutical applications. From a single global source, backed by the expertise of a worldwide engineering and manufacturing network, it partners with its customers in all stages of development, from concept to serial production, providing the optimum solutions to meet all their partners polymer-based healthcare & medical application challenges. Trelleborg Healthcare & Medical combines a number of operations from within Trelleborg Group that are focused on this industry. trelleborg.com, tss.com
Trelleborg is a world leader in engineered polymer solutions that seal, damp and protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. The Trelleborg Group has annual sales of about SEK 34 billion (EUR 3.32 billion, USD 3.92 billion) and operations in about 50 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Sealing Solutions and Trelleborg Wheel Systems, and a reporting segment, Businesses under development. The Trelleborg share has been listed on the Stock Exchange since 1964 and is listed on Nasdaq Stockholm, Large Cap. trelleborg.com