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New edition for the EN ISO 14971: what impact for MD manufacturers?

In spite of the proposal to postpone the full adoption of the medical device Regulation 2017/745 (MDR) currently under discussion, manufacturers should not underestimate all the new or updated requirements compared to Directive 93/42/EEC (MDD) and get ready for their implementation. In this context, the publication of the third edition of the technical standard EN ISO 14971, on the management of medical device (MD) risks, should not be overlooked. Although its previous edition (EN ISO 14971:2012) was a harmonised norm for the MDD, it is plausible that manufacturers will be required to comply with the latest edition of the standard (EN ISO 14971:2019).

It is important to stress that the EN ISO 14971:2019 do not alter the risk management process as defined in the previous edition, however it basically clarifies some aspects, already considered before, specifying in details the activities to be implemented.

It is confirmed that risk management is the result of a continuous process that should not be limited to the drafting of a report when the documentation of the MD technical dossier is collected.

The list that follows include the main novelties of the new edition:

  • Addition of the definitions of benefit, reasonably unforeseen improper use, and state of the art.
  • More attention given to the benefit deriving from the MD use (that, though mentioned, was less relevant at the end of the risk assessment in the previous version).
  • Clarifications on the relation between a hazard and a hazardous situation.
  • The need to make explicit the methods for the risk assessment, the acceptability criteria and the activities for the verification of the implementation and effectiveness of the measures taken for risk management within the risk management plan.
  • The introduction of a new phase in the risk analysis process, i.e. the identification of the product characteristics with a direct impact on safety.
  • The possible inclusion of risks related to data/system safety in the risk management process.
  • It is clarified that the residual risk assessment is to be carried out considering all individual risks in relation to the benefits associated with the MD use. In particular, for each analysed residual risk, if medical benefits from the use of the product do not exceed the damage faced by the user, then the risk remains unacceptable. In this case, the manufacturer will consider all possible changes to the medical device, including a review of its intended use.
  • The obligation for the manufacturer to inform the user about significant residual risks and to include all required information on them in the documentation accompanying the MDs.
  • The definition of further details as far as the requirements for manufacturing and post-manufacturing activities are concerned, any information to be collected as well as any action to be taken.

The norm dedicates a whole chapter on this last point. In particular, all collection activities shall be managed in compliance with a quality management system and include information generated:

  • during manufacturing or manufacturing control,
  • by the user,
  • in the supply chain or public information related to the state of the art.

Once all the above information has been collected, even proactively, manufacturers shall verify that they do not have any impact on the risk analysis carried out so far. In the case they do, great attention shall be paid to safety issues.

Finally, it should be stressed that much information that was included in the previous edition of the standard EN ISO 14971 was moved into the guideline ISO/TR 24971, that at March 2020 had not been published yet.

Written by: Daniele Scarpino