New natio­nal laws for the medi­cal devices industry

EU frame­work conditions

Two Regu­la­ti­ons, the MDR and IVDR, will soon replace the EU Direc­ti­ves curr­ent­ly in effect for medi­cal devices and in-vitro dia­gno­stics. As EU law, they will be appli­ed direct­ly in the mem­ber sta­tes and do not requi­re expli­cit imple­men­ta­ti­on into natio­nal law.

Medi­cal Devices Act on its way out, Medi­cal Devices Imple­men­ting Act on its way in

Accor­din­gly, the Ger­man Medi­cal Devices Act, which remains in effect, is no lon­ger neces­sa­ry as the imple­men­ting sta­tu­te for the Direc­ti­ves, as curr­ent­ly amen­ded. It will be repla­ced by the Medi­cal Devices Imple­men­ting Act, which will estab­lish bin­ding rules for manu­fac­tu­r­ers and ope­ra­tors of medi­cal devices in Ger­ma­ny, as well as for other eco­no­mic ope­ra­tors. It includes pro­vi­si­ons which have to be enac­ted in natio­nal legis­la­ti­on, and not in an EU Regu­la­ti­on. This is par­ti­cu­lar­ly the case for pen­al­ties (pri­son sen­ten­ces and fines), pro­vi­si­ons con­cer­ning the juris­dic­tion of natio­nal aut­ho­ri­ties and other are­as whe­re spe­ci­fic natio­nal legis­la­ti­on is requi­red. Howe­ver, the lat­ter pro­vi­si­ons must not con­flict with the pro­vi­si­ons of the MDR and IVDR or have the effect of hin­de­ring com­pe­ti­ti­on. The Medi­cal Devices Imple­men­ting Act forms part of the “Medi­cal Devices EU Adjus­t­ment Act” and has exis­ted in the form of a depart­ment­al bill (PDF) sin­ce 25 August 2019.

Safe­ty offi­cer and medi­cal devices advisor

Unli­ke the Medi­cal Devices Act, the Medi­cal Devices Imple­men­ting Act no lon­ger requi­res a safe­ty offi­cer. In the future, manu­fac­tu­r­ers will be requi­red to com­mu­ni­ca­te “safe­ty cor­rec­ti­ve actions,” but the­re is no lon­ger any need to express­ly appoint an inhouse safe­ty offi­cer for this pur­po­se. The tasks of the “per­son respon­si­ble for regu­la­to­ry com­pli­ance” at the manu­fac­tu­rer in accordance with Artic­le 15 of the MDR do not include the duties of the safe­ty offi­cer as curr­ent­ly unders­tood in Ger­man law. The situa­ti­on is other­wi­se with the “figu­re” of the medi­cal devices advi­sor, which is retai­ned in the Medi­cal Devices Imple­men­ting Act. The requi­re­ments for exper­ti­se in the sub­ject and the pro­duct have also been retained.

Cli­ni­cal eva­lua­tions and per­for­mance evaluations

The MDR and IVDR focus in par­ti­cu­lar on the con­duct of cli­ni­cal inves­ti­ga­ti­ons and impo­se stric­ter requi­re­ments for cli­ni­cal inves­ti­ga­ti­ons than in the Direc­ti­ves. This cir­cum­s­tance is accoun­ted for in the Medi­cal Devices Imple­men­ting Act, which dic­ta­tes the con­di­ti­ons for cli­ni­cal inves­ti­ga­ti­ons at length, from the appli­ca­ti­on pro­ce­du­re through con­duct of the tri­als and moni­to­ring. In fact, the Medi­cal Devices Imple­men­ting Act actual­ly goes bey­ond the requi­re­ments in the MDR. For exam­p­le, the Medi­cal Devices Imple­men­ting Act requi­res manu­fac­tu­r­ers to obtain appr­oval from the supre­me fede­ral aut­ho­ri­ty befo­re laun­ching a cli­ni­cal inves­ti­ga­ti­on even for less-than-critical pro­ducts. The requi­re­ments for cli­ni­cal inves­ti­ga­ti­ons who­se sub­jects requi­re spe­cial pro­tec­tion, the gui­de­lines for coope­ra­ti­on with the ethics com­mit­tee and the requi­re­ments for the pro­tec­tion of per­so­nal data coll­ec­ted in cli­ni­cal inves­ti­ga­ti­ons are also more detail­ed in the Medi­cal Devices Imple­men­ting Act than in the MDR.

Addi­tio­nal requirements

The­re are also other pro­vi­si­ons of the Medi­cal Devices Imple­men­ting Act which go bey­ond the requi­re­ments of the MDR. For exam­p­le, the­re is a regis­tra­ti­on requi­re­ment for com­pa­nies enga­ged in the ste­ri­liza­ti­on or near-sterilization of medi­cal devices and for manu­fac­tu­r­ers of Class III implan­ta­ble custom-made devices. The lan­guage requi­re­ment is unsur­pri­sing: accom­pany­ing mate­ri­als for medi­cal devices must be in Ger­man. Excep­ti­ons may only be made in indi­vi­du­al cases, and only for pro­fes­sio­nal users.


The fami­li­ar penal­ty sca­le from the Medi­cal Devices Act, cal­ling for pri­son sen­ten­ces of 3 and 5 years, remains unch­an­ged. Howe­ver, addi­tio­nal offen­ses have been included in the Medi­cal Devices Imple­men­ting Act. For exam­p­le, com­men­cing or con­duc­ting cli­ni­cal investigations/performance eva­lua­tions which con­flict with the requi­re­ments of the MDR/IVDR, mar­ke­ting pro­ducts which are not pro­per­ly regis­tered and affi­xing mis­lea­ding state­ments to the pro­duct and/or accom­pany­ing mate­ri­als have been new­ly included or rede­fi­ned as offen­ses for which pen­al­ties may be imposed.

Recom­men­ded actions

Manu­fac­tu­r­ers would be well-advised to acquaint them­sel­ves with the con­tent of the Medi­cal Devices Imple­men­ting Act, espe­ci­al­ly com­pa­nies plan­ning on mar­ke­ting their pro­ducts in Ger­ma­ny or con­duc­ting cli­ni­cal investigations/performance eva­lua­tions or pro­duct ste­ri­liza­ti­ons in Ger­ma­ny as a ser­vice pro­vi­der. Both the MDR and the Medi­cal Devices Imple­men­ting Act app­ly in Ger­ma­ny!
In par­ti­cu­lar, manu­fac­tu­r­ers should exami­ne their exis­ting ope­ra­ting pro­ce­du­res and revi­se them if neces­sa­ry. Par­ti­cu­lar atten­ti­on should be paid to the pro­vi­si­ons of the Medi­cal Devices Imple­men­ting Act with regard to cli­ni­cal inves­ti­ga­ti­ons, regis­tra­ti­on requi­re­ments and vigi­lan­ce, which are more detail­ed than tho­se of the MDR. Adhe­rence to the MDR’s requi­re­ments alo­ne is not enough: it is also neces­sa­ry to com­ply with the Medi­cal Devices Imple­men­ting Act.


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