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Commission publishes updated lists of harmonised standards for Directives

  • Posted by: inetika
  • Category: GLOBAL NEWS

The Official Journal (OJ) of the European Communities of 26 March 2020 includes Council Decisions and lists of standards that have now been ratified by the European Commission as ‘harmonised standards’, conferring ‘presumptions of conformity’ with the applicable Essential Requirements of the three device directives, these being:

  • Medical Device Directive (MDD, 93/42/EEC)
  • Active Implantable Medical Device Directive (AIMDD, 90/385/EEC)
  • In Vitro Diagnostic Device Directive (IVDD, 98/79/EC)

A copy of the OJ can be accessed from here.

It would appear that the Covid-19 crisis has spurred the Commission into action on the standards front, as explained in this press release.