MDR com­pli­ance for Class I medi­cal devices

The fami­li­ar EU Direc­ti­ves rela­ting to the manu­fac­tu­re and sale of medi­cal devices, Direc­ti­ve 90/385/EEC on acti­ve implan­ta­ble medi­cal devices (AIMD), Direc­ti­ve 93/42/EEC (PDF) con­cer­ning medi­cal devices (MDD) and Direc­ti­ve 98/79/EC on in-vitro dia­gno­stic medi­cal devices (IVDD), curr­ent­ly remain in effect. They have been imple­men­ted into natio­nal law in Ger­ma­ny by the Medi­cal Devices Act (only in Ger­man) and the Ordi­nan­ces enac­ted under that statute.

Upon expi­ra­ti­on of the various tran­si­tio­nal peri­ods, the cur­rent Direc­ti­ves will be repla­ced by the two EU Regu­la­ti­ons which have alre­a­dy taken effect, Regu­la­ti­on (EU) 2017/745 on medi­cal devices (MDR) and Regu­la­ti­on (EU) 2017/746 on in-vitro dia­gno­stic medi­cal devices (IVDR). Due to the out­break of the coro­na­vi­rus pan­de­mic, the ent­ry into effect of the MDR was post­po­ned by one year, to 26 May 2021. Once the Regu­la­ti­on enters into effect, it will not requi­re imple­men­ta­ti­on into natio­nal law, so that the Medi­cal Devices Act will no lon­ger be in effect in its cur­rent form. Once the MDR takes effect, the Medi­cal Devices Act will be repla­ced by the Imple­men­ting Act for Medi­cal Devices Law [Medizinprodukterecht-Durchführungsgesetz] (PDF only in German). 

The com­pe­tent super­vi­so­ry aut­ho­ri­ties are alre­a­dy con­duc­ting regu­la­ti­on in cogni­zan­ce of the fact that the pro­vi­si­ons of the MDR will take bin­ding effect as of 26 May 2021. In par­ti­cu­lar, manu­fac­tu­r­ers of Class I medi­cal devices will have no addi­tio­nal tran­si­tio­nal peri­od after 26 May 2021: Class I devices will be requi­red to meet the requi­re­ments of the MDR as of that date!

Accor­din­gly, the fol­lo­wing steps need to be taken for the pla­ce­ment on the mar­ket of Class I medi­cal devices in accordance with the MDR (based on the atta­ched Medi­cal Device Coor­di­na­ti­on Group (MDCG) gui­dance docu­ment) (PDF).

1.    Con­firm that the pro­duct is a medi­cal device

This is the case e.g. with respect to medi­cal face masks/OP masks.

2.    Check whe­ther the pro­duct was cor­rect­ly clas­si­fied as a Class I medi­cal device

3.    Make sure that the device meets the gene­ral safe­ty and per­for­mance requi­re­ments spe­ci­fied in Annex I to the MDR

In par­ti­cu­lar, manu­fac­tu­r­ers are to per­form a risk-benefit ana­ly­sis as part of their risk manage­ment sys­tems. Har­mo­ni­zed stan­dards and com­mon spe­ci­fi­ca­ti­ons may be used to docu­ment com­pli­ance with the appli­ca­ble requirements.

4.    Con­duct a cli­ni­cal evaluation

The MDCG express­ly stres­ses the importance of the cli­ni­cal eva­lua­ti­on for the MDR and notes that the MDR requi­res manu­fac­tu­r­ers, par­ti­cu­lar­ly manu­fac­tu­r­ers of Class I medi­cal devices, to ana­ly­ze and compa­re alter­na­ti­ve devices, take into account post-market data, demons­tra­te the accep­ta­bi­li­ty of the benefit-risk ratio based on cli­ni­cal data and con­duct cli­ni­cal inves­ti­ga­ti­ons if and when the available cli­ni­cal or per­for­mance data is insufficient.

5.    Prepa­re tech­ni­cal documentation

Manu­fac­tu­r­ers of Class I medi­cal devices must also prepa­re tech­ni­cal docu­men­ta­ti­on as spe­ci­fied in Anne­xes II and III to the MDR. The MDR intro­du­ces various chan­ges rela­ti­ve to the Direc­ti­ves which are curr­ent­ly in effect. For exam­p­le, a ratio­na­le must be cited for the clas­si­fi­ca­ti­on and a basic UDI-DI must be assi­gned. A refe­rence to pre­vious gene­ra­ti­ons of the device and simi­lar devices must also be included, if appli­ca­ble. Refe­rence should also be made to the valid har­mo­ni­zed stan­dards and “com­mon spe­ci­fi­ca­ti­ons” which have been appli­ed and the post-market sur­veil­lan­ce sys­tem must be descri­bed as well.

6.    Prepa­re ins­truc­tions for use and labeling

In excep­tio­nal cases, ins­truc­tions for use may be dis­pen­sed with for Class I devices if the devices can be used safe­ly wit­hout ins­truc­tions for use, in accordance with Annex I Chap­ter III No. 23.1(d) of the MDR. If ins­truc­tions for use are requi­red, natio­nal lan­guage requi­re­ments must be taken into account. The sym­bols used in labe­l­ing are to con­form to the har­mo­ni­zed standards/common spe­ci­fi­ca­ti­ons. The pro­duct must be labe­led as a “medi­cal device.”

7.    Estab­lish a QM system

Manu­fac­tu­r­ers, inclu­ding manu­fac­tu­r­ers of Class I medi­cal devices, are requi­red to estab­lish and main­tain a QM sys­tem. They are also requi­red to appoint a per­son respon­si­ble for regu­la­to­ry com­pli­ance in accordance with Artic­le 15 of the MDR.

8.    Draw up an EU Decla­ra­ti­on of Con­for­mi­ty (inclu­ding trans­la­ti­ons into the natio­nal lan­guages of the count­ries in which the device will be made available).

9.    Affix the CE marking

10.    Regis­ter the device and manu­fac­tu­rer with DIMDI (in the future: the EUDAMED database)

11.    Imple­ment a post-market sur­veil­lan­ce system

the MDR requi­res manu­fac­tu­r­ers to estab­lish a post-market sur­veil­lan­ce sys­tem as part of their QM sys­tem. Manu­fac­tu­r­ers of Class I medi­cal devices are requi­red to prepa­re a “post-market sur­veil­lan­ce report.”

12.    Imple­ment a vigi­lan­ce system

in accordance with the MDR, manu­fac­tu­rer of Class I medi­cal devices are also requi­red to report “field safe­ty cor­rec­ti­ve actions” (FCSAs). Until the EUDAMED data­ba­se is ope­ra­tio­nal, such reports in Ger­ma­ny will be made to the Fede­ral Insti­tu­te for Drugs and Medi­cal Devices (BfArM). Even­tual­ly, the­se reports will be added to the EUDAMED data­ba­se. In addi­ti­on to their exis­ting report­ing duties, manu­fac­tu­r­ers are requi­red to take cor­rec­ti­ve actions if they beco­me awa­re that their devices are non-conforming.

Sum­ma­ry and recommendation

The MDR’s requi­re­ments are far from tri­vi­al, par­ti­cu­lar­ly when it comes to Class I medi­cal devices. In par­ti­cu­lar, the­re is no way around the cli­ni­cal eva­lua­ti­on for the­se manu­fac­tu­r­ers, con­tra­ry to the wide­ly dis­se­mi­na­ted views of many eco­no­mic ope­ra­tors. Manu­fac­tu­r­ers would be well-advised to take advan­ta­ge of their extra time, now that the MDR’s ent­ry into effect has been post­po­ned due to the coro­na­vi­rus pan­de­mic, to ensu­re that their com­pa­nies and pro­ducts com­ply with the MDR.


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