Keeping Compliant

Testing-Mis
Date: 24.04.21
Global Standards for medical devices are continually becoming more stringent. The EU Regulation on Medical Devices 2017/745 (MDR) is one of the most recent changes, and we’re helping our customers to stay  compliant. - By Donna Guinivan

THE LATEST EU REGULATION ON MEDICAL DEVICES

2017/745 (MDR), which was issued on 5 April, 2017 will go into effect in EU Member States on 26 May 2021. It applies to medical devices, which means any device for human beings that is determined for diagnosis, prevention, monitoring, treatment of diseases, injuries or disabilities, modification of the anatomy or contraception.


A challenging regulation

 

“Our focus is on supporting our Healthcare & Medical customers to bring products to market faster, while ensuring consistent, reliable supply and the highest quality,” says Manuel Funk, Technical Manager at Trelleborg Healthcare & Medical in Europe. “To that end, we’ve invested significant time and effort in understanding Europe’s latest changes to MDR.”

 

“Meeting the regulation is challenging, and it goes hand in hand with complying with other standards that are applicable to medical devices, such as ISO 10993,” says Verena Hoerner, Project Development Engineer at Trelleborg Healthcare & Medical.

 

“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 our offering to our customers; we provide material expertise to support them in complying with the new, very demanding MDR guidelines and mitigate risk to the highest extent.”

Testing-Mis
Investment in testing

Verena adds, “In complying to MDR, our attention was on material related requirements, like carcinogenic, mutagenic, or reproductive toxic (CMR) substances, endocrine disruptors, phthalates and nanomaterials.” 

 

Trelleborg Healthcare & Medical performed extensive testing to examine that its materials support the stringent requirements of the new regulation. This involved cooperation with certified laboratories as well as investment in advanced analytical instrumentation, such as a coupled GC-MS (gas chromatography – mass spectrometry) for extraction studies. Conducting of tests were in worst case scenarios.

 

Any substances identified were then checked against MDR requirements. Providing this information to customers supports them in making their medical device compliant to EU Regulation on Medical Devices 2017/745, as well as other relevant regulations and standards.

 

Always working on compliance

“Meeting the latest standards and regulations is vital for us as a supplier to our medical device customers who rely on us to have offerings ready that comply to global requirements. We never rest on our laurels, and once we have satisfied one set of needs, we move onto the next, using our existing material portfolio or newly developed compounds, if  required,” concludes Manuel.