WMDE

"Experience you can Trust"

Regulatory Affairs

Regulatorry Affairs Medical Devices:

WMDE B.V. can assist you with Regulatory Affairs for all classes medical devices and IVD's. We have over 30 years expertise you can trust and have been working for Fortune 500 medical device companies as well as start-up's or midsized medical device or IVD companies.

CE-Marking:

Why is CE-marking for medical devices needed?

CE-marking is a legal requirement for medical devices, which are sold in Europe.

There are three European Directives that lead to CE-marking for medical devices:

  • Medical Devices Directive (MDD) 93/42/EEC - applies to all general medical devices
  • Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC - applies to all devices with a power supply intended to be implanted in humans
  • In Vitro Diagnostics Directive (IVDD) 98/79/EC- applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions

WMDE can assist in the entire CE-Marking process for Medical Devices

Our services for CE-marking include:

  • Medical device classification
  • Technical file preparation and review
  • Language requirements per country
  • Medical device regulation
  • Mdd medical device directive
  • European medical device directive
  • Ce regulations
  • Authorized European Representation
  • Determination of certification process/conformity assessment route
  • Notified Body search
  • Notifications and registrations with competent authorities
  • Clinical evidence evaluation
  • Vigilance procedure and post market surveillance procedures development
  • Functionality test requirements
  • Biocompatibility test requirement
  • Packaging
  • Microbiological procedures
  • Supplier audits
  • MDD: 93/42/EEC
  • IVDD: 98/79/EC
  • AIMD: 90/385/EEC
  • Ce marking directive
  • Ce compliance
  • Ce-certification
  • Ce mark medical device
  • Registration
  • Consult medical
  • Medical device consulting firms
  • Mdd eu
  • Ce declaration of conformity
  • Medical devices

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If you have any questions, please contact us by e-mail or telephone: +31 (0)475 58 22 85

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