Medical devices (MD) including substance-based medical devices (oral or topical products) exert their beneficial effects mainly by physical action.
In vitro diagnostic medical devices (IVD) are all tests that provide information on a physiological state or disease predisposition based on the examination of specimens derived from the human body, including devices for self-testing or near-patient testing.
During the past 10 years, a&r has supported its customers in the certification of numerous medical devices covering various indications such as wound healing, weight management, atopic dermatitis, Herpes simples, allergic rhinitis, or periodontosis. A&r is familiar with the compilation of the Technical Documentation for all risk classes and cooperates with national and international Notified Bodies.
In May 2017 the new Medical Device Regulation (EU) 2017/745 (MDR) entered into force. The MDR replaces the Medical Device Directive (MDD; 93/42/EEC).
For in vitro diagnostic medical devices (IVDR) the new Regulation (EU) 2017/746 entered into force in May 2017. The IVDR replaces the IVD Directive 98/79/EC (IVDD).
Manufacturers need to update their Technical Documentation for all medical devices according to MDR or IVDR in order to meet the respective CE requirements.