Medical Devices and In Vitro Diagnostic Medical Devices

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.

Regulatory Affairs and CE-Certification

Our services include:

  • Competent and flexible support at any stage of the product development, from initial idea to market access
  • Clarification of demarcation issues (medical device – food – drug)
  • Assessment of medical device risk classification according to MDR or IVDR
  • Check of regulatory requirements for a medical device
  • Gap analysis pre-market and throughout the product life cycle
  • Consultation procedure in case of medical devices with pharmacological substances
  • Correspondence with Notified Bodies
  • Coordination and performance of studies, e.g. biocompatibility testing, transportation evaluation, usability studies and clinical studies supporting performance and safety of the device
  • Compilation of the Technical Documentation; including e.g.
    • Biological Safety Evaluation Report
    • Substance-Based Device Information (SBDI, for substance-based MD)
    • Clinical Evaluation Plan and Report
    • Performance Evaluation Plan and Report (for IVD)
    • Post-Market Clinical Follow-up (PMCF) Plan and Report
    • Post-Market Performance Follow-up (PMPF) Plan and Report (for IVD)
    • Transportation Evaluation Report
    • Periodic Safety Update Report (PSUR)