Eurom High-Tech Industries

Medical Technology

Medical Technology Committee

The Medical Technology Committee is the working platform for national associations and manufacturers of Medical Devices and IVD’s within eurom. The committee meets on a monthly basis and has a strong focus on regulatory issues, such as supporting the activities of the Medical Device Coordination Group (MDCG).

Chairs

Dr. Guido Middeler – Committee Chair

guido.middeler@diapharm.de

Ralf Klein – Vice Chair

klein@radimed.de

Medical Devices

  • Inhalation, anaesthetic, ventilatory and oxygen devices, and interrelated safety and patient monitoring equipment
  • Medical gas supply systems and interrelated monitoring equipment
  • Incubators and interrelated monitoring equipment
  • Pressure and climatic chambers
  • Furniture for hospitals
  • Operating tables
  • Surgical lights
  • Reusable infusion and transfusion devices and pumps, reusable syringes, and cannulas
  • Surgical and diagnostic instruments and devices for medical veterinary surgery
  • Dental instruments, devices, and burrs (medical and technical)
  • Endoscopes
  • Optic medical instruments and devices, including operation microscopes, and lasers
  • Ophthalmological instruments and devices
  • Non-active endoprosthesis and osteoimplants
  • Orthoses and orthopaedic products
  • Prostheses and fitting parts for orthopaedic appliances
  • Wheelchairs
  • Instruments and devices for rehabilitation
  • Medical compression stockings and hosieries
  • Clinically used sterilisers and their accessories

Topics of interest

  • European Regulation for Medical Devices EU 2017/745 (MDR)
  • European Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR)
  • Other New Legislative Framework (NLF) legislation (Machinery, Low Voltage, Radio Equipment Directive, Blue Guide and others
  • Unique Device Identification (UDI)
  • Eudamed
  • Standards
  • International matters, IMDRF
  • Cybersecurity and Artificial Intelligence
  • Digital Health
  • Electronic instructions for use
  • Environmental and circular economy legislation (e.g. Green Deal, Circular Economy Action Plan, Chemical Strategy for Sustainability, in particular but not limited to WEEE, ROHS, REACH, CLP, Biocidal Products Regulation, POP Regulation, Eco-design, Battery Regulation, Green claims, Packaging, SCIP)
  • Market development/ statistics in Europe and worldwide

eurom – Medical Technology

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