Regulatory requirements in the medical technology industry are complex and getting tighter almost every year. Continuous changes and amendments to the rules mean there’s a lot to keep up with, and medtech manufacturers are required to prove compliance to the regional regulation if they wish to market their products in the area. The process behind achieving such approval can be incredibly long and complicated, therefore securing a supply chain of companies that you can also turn to for support along the way is a valuable asset for a medical device manufacturer.
Elkem Silicones is a leading provider of medical-grade silicone materials to the medtech industry. Ideal for the manufacturing of premium medical components and devices, its biocompatible Silbione™ range of products meet the strictest of medical regulations for use in surgical, prosthetic, dental and many other safety-critical applications.
The team at Elkem are dedicated to the success of their customers, yet no success is possible in the medical industry without regulatory clearance. During a recent webinar, the company’s healthcare market manager for EMEA, Clement des Courières, explained how Elkem helps its customers along their journeys to regulatory approval.
A case study was shared involving a large medtech company that was testing Silbione in a Class IIa medical device aimed to be available on the European market in 2022. The customer had already received a technical data sheet (TDS) and biocompatibility statement according to ISO 10993. They later got in touch with a request for additional documentation, which Elkem was happy to provide.
According to des Courières, their request was linked to recent evolutions in European and global regulations. The single biggest change was the recent implementation of the EU Medical Device Regulation (MDR ), which aims to better mitigate risk by prioritising patient safety from raw material extraction all the way to the end marketing of the product.
EU MDR, REACH and Substances of Very High Concern
In section 10.4, EU MDR outlines the manufacturer’s obligation to verify the presence of a list of carcinogenic, mutagenic and reprotoxic (CMR) substances and endocrine disruptors that may be harmful to human health. Cooperating with a material supplier like Elkem , who is always ready to provide attestations that prove the absence of these substances, will streamline this process.
Also enforced in the EU, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH ) Regulation is another ruling with important implications for the medical device industry. Central to the regulation, REACH requires any suppliers of finished products that contain a compound included on its Candidate List of Substances of Very High Concern (SVHC) in a concentration above 0.1% (w/w) to inform their customers and provide the recipient with information on safe use of the article.
In 2018, the D4, D5 and D6 oligomers were added to the REACH Candidate List due to properties regarding their persistence and bioaccumulation. Elkem can provide attestations about the potential residual quantity of SVHC substances in their formulations and also offers a service where it helps customers analyse the quantity of these impurities in their final product, as it can be impacted by typical silicone curing processes. Moreover, in a strong effort to continuously improve and shape a more sustainable future, the silicone supplier is working hard to significantly reduce the presence of D4, D5 and D6 impurities in its products.
Elkem’s regulatory support
In a highly regulated industry where medtech companies are put under an increasing amount of pressure to comply with tighter regulations year on year, Elkem Silicones’ approach to regulatory support stands out. While Elkem is not responsible for the compliance of its customers’ end products, the company is more than willing to assist customers on a personalised case-by-case basis. Its global team of regulatory experts and toxicologists work both internally and with customers to respond to a range of regulatory requests from medtech companies based not only in Europe but all around the world.
From providing attestations and ISO quality management certificates, to giving access to MAF/DMF files, signing supply quality agreements, and in some cases even disclosing the product’s chemical composition under NDA, Elkem Silicones shows itself to be much more than a material supplier to medtech companies.