The medical device market has a duty to patients to ensure that their products are safe and free from harm. However, this is not always an easy task, as manufacturers have not yet mastered all of the nuances involved in body implants. For instance, CNN reported last year that a company in France was found to have developed industrial-grade breast implants, which have more contaminants than the approved medical-grade gel.
The implants were then banned and authorities advised thousands of women to remove the possibly defective devices. All of this sparked debate among Europe and lawmakers began creating new ways to regulate medical devices.
Reuters reported this week that some businesses that make implantable devices, like heart stents or new hips, claim that a complete overhaul of the regulation system will put a damper on creativity and the release of new devices.
The European Commission has already brought forth a proposal for regulation improvements while the European Parliament is looking to have an entire new system of pre-market approval.
“We absolutely need that,” Dagmar Roth-Behrendt, a lawmaker from Germany sitting on the board, told Reuters. “We don’t need it for every medical device, but for certain medical devices, without any doubt, we need a more stringent prior authorization system.”
With the governments across Europe seeking more stringent regulations and higher quality medical devices, it becomes more important than ever for manufacturers in the biomedical sector to meet the needs of their consumers.
Materials testing is a necessity that manufacturers need to take part in before bringing their products to market. ADMET offers a multitude of biomaterials and tissues testing machines for the biomedical industry. Medical device manufacturers, healthcare research laboratories and top universities seek the help of ADMET to meet specific ASTM and ISO regulations, such as ASTM F543, ASTM F382, or ISO 594.