With the start of application of the Medical Device Regulation (MDR) in 2021, the regulatory requirements for medical devices will increase. Among others, this applies also to manufacturers who want to bring substance-based medical devices to market. Notably, the necessary certification by Notified Bodies might emerge as a problem. Due to the Corona pandemic, the start of the validity of the European Medical Devices Regulation had been postponed for 12 months.
Examples for substance-based medical devices include drops for the treatment of dry eyes, nose sprays based on seawater, laxatives, products for bloating and gastrointestinal pain, various gels, creams and ointments. In contrast to medicinal products, substance-based medical devices do not achieve their intended purpose by a pharmacological, immunological or metabolic mode of action. The new Medical Device Regulation is the result of a long law-making process which was kicked-off in 2012. It will be immediately applicable in all EU Member States. Implementation into national law is not necessary. Consequently, the law will become far more extensive and more than before be dominated by European rules. Not only will regulatory density increase, but the character of rules will also change. Substance-based medical devices will have to face multiple tightenings of rules.