ISO 14155:2011 is here: revised standards for medical devices clinical trials

ISO 14155, who in medical devices  is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the 2009 version that introduced a more project management oriented approach (the 2003 harmonised version ceased to apply in the EU as of 21 March 2010) the IEC published the long-awaited new version of the ISO 14155 with its new requirements and which consolidates the two parts.

According to the ISO summary the scope of 14155:2011 is

good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Remember, ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

Companies should start to prepare for the implementation of IsO 14155:2011 because there are quite a few changes compared to the old standards. It’s important to realize that there is no transitional period after the EU harmonises the standard and your company’s clinical investigations will need to meet the new standard. Companies should rather use the period of publication by ISO and harmonisation by the EU (which may be several months) as sunshine period for becoming compliant. This is particularly important for

  • studies that will be finalised in this Sunshine period; and
  • studies that are in the process of being set up and start after the publication of the harmonised EN 14155:2011.

Companies should make sure that they have informed themselves how the entry into force by way of the new standard being harmonised by the EU will impact their ongoing and planned studies. Companies that get it wrong may face a difficult discussion with their notified body that will not be able to accept the clinical investigation, which will delay issuance of the CE certificate and may cause companies to have to redo administrative work, or, in the worst case, a trial that was not set up according to the new rules.


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