Health care update: MDR mora­to­ri­um, natio­nal legis­la­ti­on, COVID-19

The coro­na­vi­rus pan­de­mic and awa­re­ness of the resul­ting bur­den on all eco­no­mic ope­ra­tors in the health care sec­tor have recent­ly accom­plished some­thing which see­med unthinkable at the begin­ning of the year: Euro­pean law­ma­kers have been pre­vai­led upon to post­po­ne the effec­ti­ve date of the MDR by one year, to 26 May 2021.

For many eco­no­mic ope­ra­tors, this post­po­ne­ment was an urgen­tly neces­sa­ry step which allows them to con­ti­nue pla­cing medi­cal devices on the mar­ket for ano­ther twel­ve months in accordance with the fami­li­ar EU Direc­ti­ves. But at the same time, post­po­ning the effec­ti­ve date does not eli­mi­na­te all obs­ta­cles on the path towards com­pli­ance with the MDR. For exam­p­le, the tran­si­tio­nal peri­od in accordance with Artic­le 120 of the MDR for the tole­ra­ti­on of medi­cal devices which were pla­ced on the mar­ket in con­for­mance with the appli­ca­ble Direc­ti­ves will be shor­ten­ed from four to three years. The ori­gi­nal expi­ra­ti­on date for this tran­si­tio­nal peri­od (26 May 2024) is unch­an­ged by the moratorium.

Ano­ther pro­blem at the moment is sup­port for manu­fac­tu­r­ers by noti­fied bodies in asses­sing the con­for­mi­ty of new medi­cal devices: on-site audits are still impos­si­ble for many manu­fac­tu­r­ers due to social distancing rules. At the same time, the “Gui­dance on tem­po­ra­ry extra­or­di­na­ry mea­su­res rela­ted to medi­cal device Noti­fied Body audits during COVID-19,” dated 8 April 2020, makes no pro­vi­si­on for remo­te audits, whe­ther for initi­al cer­ti­fi­ca­ti­on audits or for audits to extend the scope of cer­ti­fi­ca­ti­on. The lon­ger on-site audits are post­po­ned as a result of the lock­down, the shorter the tran­si­tio­nal peri­od will be.

The­se pro­blems are exa­cer­ba­ted by the num­ber of noti­fied bodies which are accre­di­ted under the MDR’s rules, which con­ti­nues to be limi­t­ed. The EU Com­mis­si­on has cle­ar­ly fal­len short of its sta­ted goal of accre­diting 20 noti­fied bodies by the end of 2019. As things stand today (8 June 2020), only 14 bodies have been accre­di­ted accor­ding to the Nan­do data­ba­se.

It is also to be expec­ted that the Euda­med data­ba­se, a key ele­ment of the MDR, will not be usable until 26 May 2022 at the earliest.

The­re con­ti­nues to be a need for legis­la­ti­on and gui­de­lines to crea­te more legal cer­tain­ty for ope­ra­tors in the indus­try. Alt­hough the decis­i­on to post­po­ne the MDR’s effec­ti­ve date has been wel­co­med by indus­try repre­sen­ta­ti­ves and eco­no­mic ope­ra­tors in the indus­try, it is also clear that, in no small num­ber of cases, the pan­de­mic is for­cing the “post­po­ne­ment” of firm­ly sche­du­led cer­ti­fi­ca­ti­on dates and mile­sto­nes for the mar­ke­ting of new medi­cal devices.

This means that is all the more important for manu­fac­tu­r­ers to stay on cour­se and main­tain their focus to ensu­re that their com­pa­nies and pro­ducts are in com­pli­ance with the MDR. They should take advan­ta­ge of the time they “gain” to clo­se any remai­ning gaps bet­ween the cur­rent sta­tus in accordance with the MDD and the future sta­tus under the MDR.


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