ISO 14971 is a glob­al risk man­age­ment stan­dard that has just been updat­ed in keep­ing with tech­no­log­i­cal and reg­u­la­to­ry changes in the medtech indus­try. In the EU, the stan­dard is rel­e­vant to all med­ical devices and IVDs and rein­forces the cur­rent med­ical device direc­tives and the future med­ical devices and IVD reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR). 

The Role of ISO14971:2019 for the MDR and IVDR and har­mon­i­sa­tion status

Risk man­age­ment has to be includ­ed at every lev­el into a manufacturer’s qual­i­ty sys­tem and needs to be explained in the tech­ni­cal doc­u­men­ta­tion. Due to the risk-based approach in many aspects and the life-cycle prin­ci­ple inher­ent in the MDR and IVDR, the new ISO 14971 revi­sion has one of the first dead­lines of all EU stan­dards for har­mon­i­sa­tion in the con­text of the MDR and IVDR. How­ev­er, it seems unlike­ly that this will hap­pen in time in view of the short peri­od until 26 May 2020. 

Still, as an over­all prin­ci­ple, man­u­fac­tur­ers should com­ply to the state of the art

Still, as an over­all prin­ci­ple, man­u­fac­tur­ers should com­ply to the state of the art. ISO14971:2019 is the most recent stan­dard on risk man­age­ment and Noti­fied Bod­ies and com­pe­tent author­i­ties will expect at least a doc­u­ment­ed plan for com­pli­ance with the new revision. 

What are the biggest changes in the new revision? 

The three biggest changes in the new ver­sion are:

  1. The risk man­age­ment plan calls for inclu­sion of cri­te­ria for accept­abil­i­ty of indi­vid­ual resid­ual risk and over­all resid­ual risk, includ­ing the method used to estab­lish over­all resid­ual risk.
  2. A ben­e­fit risk analy­sis has to be car­ried out on each resid­ual risk, and the over­all resid­ual risks have to be assessed against the ben­e­fits of the intend­ed use.
  3. The risk man­age­ment process, includ­ing what mea­sures have to be tak­en and infor­ma­tion about pro­duc­tion and post-pro­duc­tion activ­i­ties, are bet­ter explained.

ISO 14971:2019 is a prod­uct-focused risk man­age­ment stan­dard that entails involve­ment of numer­ous process­es. The con­tent is debat­ed and decid­ed on with input from world­wide experts, indus­try and reg­u­la­tors. Using this stan­dard (and ISO TR 24971 as guid­ance) will facil­i­tate man­u­fac­tur­ers to sat­is­fy reg­u­la­tors expec­ta­tions around the world, includ­ing the EU.

Source: Medtech Insight (an Infor­ma product)

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