The for­mal stan­dard­i­s­a­tion request from the Euro­pean Com­mis­sion to the Euro­pean stan­dards bod­ies will get essen­tial stan­dards work to sup­port com­pli­ance with Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). The Euro­pean Com­mis­sion adopt­ed and issued a stan­dard­i­s­a­tion request to the EU stan­dards bod­ies in the con­text of the MDR, which now ful­ly applies 26 May 2021.

The inten­tion of the request was to ask the stan­dards bod­ies, the Euro­pean Com­mit­tee for Stan­dard­i­s­a­tion (CEN) and the Euro­pean Com­mit­tee for Elec­trotech­ni­cal Stan­dard­i­s­a­tion (CENELEC), to amend and update cur­rent med­ical device stan­dards and to out­line new stan­dards to make it pos­si­ble for man­u­fac­tur­ers to demon­strate com­pli­ance with the Gen­er­al Safe­ty and Per­for­mance Require­ments (GSPRs), which rein­force the MDR. 

Stan­dards that were assigned by the Com­mis­sion to give a pre­sump­tion of con­for­mi­ty with the essen­tial require­ments of the cur­rent med­ical device direc­tives are known as ‘har­monised stan­dards’. As the essen­tial require­ments have been super­seded in the MDR by new GSPRs, all the link­ing must be done again before man­u­fac­tur­ers can claim pre­sump­tion of con­for­mi­ty by using EU stan­dards to the GSPRs. 

Although the Commission’s move­ment in mak­ing the stan­dards request has been slow, the hope was that the one-year delay to the full appli­ca­tion date of the MDR would give more time for the revised and new stan­dards to be in place punctually. 

On June 16, 2020, how­ev­er, CEN and CENELEC reject­ed the Commission’s request. The rea­son seems to be a dis­agree­ment in the gen­er­al (Euro­pean or inter­na­tion­al) focus of the stan­dards. Man­u­fac­tur­ers who had to plan for com­pli­ance to the MDR in due time thus have anoth­er chal­lenge to meet. If no har­monised stan­dards exist, pre­sump­tion of con­for­mi­ty with the GSPR can­not be made. 

The indus­try asso­ci­a­tion MedTech Europe has issued a paper in March how man­u­fac­tur­ers could deal with this issue. You can view the doc­u­ment here.

In this con­text, it will be of essen­tial impor­tance that man­u­fac­tur­ers address any gaps that may exist between the MDR and the stan­dard they are using. (als Pul­lquote) The cor­re­spond­ing ratio­nales should be read­i­ly avail­able for sub­mis­sions to Noti­fied Bod­ies or com­pe­tent authorities.

Sources: Medtech Insight (an Infor­ma product)

For fur­ther infor­ma­tion on the MDR delay, we rec­om­mend the fol­low­ing con­tent on our website