Combination products are becoming increasingly common in both the pharmaceutical and medical device sectors, reflecting a trend towards more integrated treatment solutions. These innovative products, which combine Pharma with medical device components, must navigate a particularly complex regulatory environment. The standard for pharmaceutical manufacturing, Good Manufacturing Practice (GMP), offers a foundation, but it does not fully cover the unique requirements of the medical device aspects of combination products.
With the introduction of the Medical Device Regulation (MDR) in the EU, a new layer of regulation has been introduced, filling critical gaps in the regulatory framework of these combination products. The MDR has clear safety and performance requirements, which are crucial to ensure that these products are not only effective but also safe for patients. The aim of the MDR is to ensure patient safety and increase transparency throughout the product life cycle from design to delivery.
For industry professionals, understanding the MDR becomes not only a regulatory requirement, but also a strategic advantage. Those who master these regulations can ensure that their products not only comply with the relevant regulations but also position themselves as leaders in an increasingly regulated and competitive market.
