E-ssentials MedDev Blog

Regulatory updates for the medical device industry

Don’t get your wires crossed over wireless medical devices

They’re a godsend for usability but a real challenge for regulatory affairs. Wireless medical devices not only need to comply with medical device regulations; they also need to fulfill several directives for radio equipment, such as:

Europe: RED Directive 2014/53/EU and/or R&TTED 1999/5/EC and/or 99/005/EC

USA, Canada: FCC/ISED

Japan: MIC

Brazil: ANATEL

 

Here are some points that should be on your radar right from the start when it comes to the approval of wireless medical devices:

  • National laws and requirements, e.g. test standards and possible frequencies
  • The course of the approval process, administrative regulations, such as requirements regarding packaging and labelling
    Nomination of a local agent, if approvals are only issued to local entities
  • The competent authority for radio licences
  • The licence and/or use of existing licences of purchased radio components
  • Complete technical documentation that also includes purchased radio components

 

TÜV SÜD’s radio equipment specialists will be happy to provide further information and answer your questions on the international approval of wireless medical devices. At TÜV SÜD’s testing laboratory in Straubing, which has expanded its capacities to include testing of wireless devices, we further offer all function and safety tests that are relevant for approval. Information on the radio testing of wireless devices can be found on our website.

E-ssentials MedDev Team

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