MDCG gui­d­ance on the tran­si­tio­nal pro­vi­si­ons in Arti­cle 120 MDR

Tran­si­tio­nal rules of Arti­cle 120 MDR

Arti­cle 120, Para­graphs (2) and (3) of the Medi­cal Devices Regu­la­ti­on (EU) 2017/745 (MDR) (PDF) sta­te that devices for which valid cer­ti­fi­ca­tes are avail­ab­le that were still issued by a Noti­fied Body under the Acti­ve Implan­ta­ble Medi­cal Devices Direc­ti­ve 90/385/EEC (AIMDD) or the Medi­cal Devices Direc­ti­ve 93/42/EEC (MDD) can still be pla­ced on the mar­ket or put into ser­vice after the MDR beco­mes app­li­ca­ble. Pre­re­qui­si­te for this is that the Noti­fied Body that issued the rele­vant cer­ti­fi­ca­te in accordance with the MDD or the AIMDD con­ti­nues to car­ry out, or is able to car­ry out, appro­pria­te sur­veil­lan­ce of all requi­re­ments for the devices it has cer­ti­fied. Gui­d­ance Docu­ment 2022–4 (PDF) sum­ma­ri­ses what is expec­ted of both manu­fac­tu­rers and Noti­fied Bodies with respect to “appro­pria­te sur­veil­lan­ce” under Arti­cle 120 MDR.

QMS requi­re­ments: MDD vs. MDR

In par­ti­cu­lar, to cla­ri­fy the ele­ments to be review­ed by Noti­fied Bodies, the gui­d­ance docu­ment exp­lains cer­tain obli­ga­ti­ons of manu­fac­tu­rers with respect to their qua­li­ty manage­ment systems.

Arti­cle 120(3) MDR requi­res that devices still pla­ced on the mar­ket or put into ser­vice under MDD/AIMDD cer­ti­fi­ca­ti­on con­ti­nue to com­ply with eit­her of the­se Direc­ti­ves and do not under­go signi­fi­cant chan­ges in design or inten­ded use. The­re­fo­re, in princip­le, the qua­li­ty manage­ment sys­tem appro­ved in accordance with the gui­de­li­nes must be main­tai­ned. Howe­ver, accord­ing to the first sub­pa­ra­graph of Arti­cle 120(3) MDR, all app­li­ca­ble requi­re­ments of Chap­ter VII of the MDR on post-market sur­veil­lan­ce, mar­ket sur­veil­lan­ce, vigi­lan­ce and regis­tra­ti­on of eco­no­mic ope­ra­tors for exis­ting pro­ducts must be obser­ved ins­tead of the cor­re­spon­ding requi­re­ments in the Directives.

MDR requi­re­ments other than post-market sur­veil­lan­ce, mar­ket sur­veil­lan­ce, vigi­lan­ce, regis­tra­ti­on of eco­no­mic ope­ra­tors and pro­ducts should in princip­le not app­ly to eco­no­mic ope­ra­tors in rela­ti­on to exis­ting products. 

This is whe­re the gui­d­ance docu­ment pro­ves par­ti­cu­lar­ly hel­pful to manu­fac­tu­rers by pro­vi­ding a com­pa­ra­ti­ve table of the qua­li­ty manage­ment sys­tem requi­re­ments in the MDD and MDR, which manu­fac­tu­rers can use to cla­ri­fy which MDD or AIMDD requi­re­ments are cove­r­ed by the MDR and which are not.

Gui­d­ance for Noti­fied Bodies and super­vi­so­ry authorities

Fur­ther­mo­re, the docu­ment pro­vi­des infor­ma­ti­on on the scope of duties of Noti­fied Bodies and super­vi­so­ry aut­ho­ri­ties with regard to pro­duct sur­veil­lan­ce of exis­ting pro­ducts during the tran­si­tio­nal pro­vi­si­ons, which can also be used by manu­fac­tu­rers to see what expec­ta­ti­ons they must reck­on with regar­ding their exis­ting pro­ducts in the con­text of audits and inspections.

Recom­men­da­ti­on for action

The Coör­di­na­ti­on Group’s gui­d­ance docu­ments do not reflect the offi­cial posi­ti­on of the Euro­pean Com­mis­si­on. Hence, the recom­men­da­ti­ons are not legal­ly bin­ding. Nevertheless, they are to be unders­tood as a valu­able inter­pre­ta­ti­on aid for eco­no­mic ope­ra­tors to com­pre­hend the still new MDR and IVDR. Manu­fac­tu­rers should keep an eye on MDCG publi­ca­ti­ons and check them in terms of rele­van­ce to their own pro­ducts. Fol­lowing the gui­d­ance docu­ments and set­ting up pro­ducts in accordance with them can signi­fi­cant­ly help to avoid “trou­ble” with Noti­fied Bodies and regu­la­to­ry aut­ho­ri­ties when com­pli­an­ce with the app­li­ca­ble regu­la­ti­ons is questioned.

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