Medical Device Regulation (MDR)

Medical Device Regulation (MDR) – Regulation 2017/745 (EU) on Medical Devices

The Ger­man coun­ter­part to the term “Me­di­cal De­vice Re­gu­la­ti­on” is “Me­di­zin­pro­duk­te­ver­ord­nung”. The Eu­ro­pean Uni­on (EU) Re­gu­la­ti­on 2017/745 will be­co­me bin­ding th­roug­hout Eu­ro­pe on May 26, 2021. In this ar­tic­le you will find in­for­ma­ti­on on con­tent and im­ple­men­ta­ti­on re­gu­la­ti­ons for the me­di­cal tech­no­lo­gy industry.

EU regulation tailored to medical technology

The “Re­gu­la­ti­on (EU) 2017/745 of the Eu­ro­pean Par­lia­ment and of the Coun­cil con­cer­ning me­di­cal de­vices” was en­ac­ted al­re­a­dy on 5 April 2017. It re­places the form­er­ly ap­pli­ed “Di­rec­ti­ve 93/42/EEC con­cer­ning me­di­cal de­vices”. This ac­tual­ly me­ans for the me­di­cal tech­no­lo­gy sec­tor that the EU re­gu­la­ti­on 2017/745 sub­sti­tu­tes for the fol­lo­wing pre­vious guidelines:

  • Di­rec­ti­ve 93/42/EEC con­cer­ning me­di­cal de­vices (MDD);
  • Di­rec­ti­ve 90/385/EWG, Ac­ti­ve Im­plan­ta­ble Me­di­cal De­vices (AIMDD)

The EU bo­dies opted for a se­pa­ra­te re­gu­la­ti­on with re­gard to Di­rec­ti­ve 98/79/EC on in vi­tro dia­gno­stic me­di­cal de­vices (IVD). This gui­de­line did not find its way into the me­di­cal de­vice re­gu­la­ti­on. It is re­pla­ced by the se­pa­ra­te­ly draf­ted EU Re­gu­la­ti­on “In-Vi­tro Dia­gno­stic Me­di­cal De­vices Re­gu­la­ti­on 2017/746 (IVDR).

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Binding throughout Europe as of May 26, 2021

In con­trast to the su­per­se­ded di­rec­ti­ve, the EU Parliament’s new re­gu­la­ti­on has gai­ned an in­ter­na­tio­nal pro­fi­le. Its bin­ding va­li­di­ty ex­tends to all EU mem­ber sta­tes from the key date of May 26, 2021. It should be no­ted here that as of Oc­to­ber 2019, no na­tio­nal le­gal acts have yet been ad­opted by the in­di­vi­du­al mem­ber sta­tes. This also ap­pli­es to Ger­man spe­ci­fics, re­qui­re­ments and pe­nal pro­vi­si­ons to be en­ac­ted. A cor­re­spon­ding draft for a Ger­man im­ple­men­ting law does exist. Nevert­hel­ess, the Fe­de­ral Mi­nis­try of He­alth an­ti­ci­pa­tes tran­si­ti­on periods.

Ac­cor­ding to the exis­ting le­gal text, the a tran­si­ti­on pe­ri­od of th­ree ye­ars ap­pli­es for the im­ple­men­ta­ti­on (05/26/17 — 05/25/21*). Af­ter the dead­line at the la­test, you as a ma­nu­fac­tu­rer are ob­li­ged to sub­mit an MDR cer­ti­fi­ca­te. This is the only way you are al­lo­wed to in­tro­du­ce a pro­duct to the mar­ket for the first time.

*In the wake of the COVID-19 pan­de­mic, the ef­fec­ti­ve date of the re­gu­la­ti­on was post­po­ned to May 26, 2021. 

Aim and necessity of the new EU regulation

In es­sence, the new re­gu­la­ti­on aims at an op­ti­mi­zed, uni­form re­gu­la­ti­on for the mar­ket launch of me­di­cal tech­no­lo­gy pro­ducts. The fo­cus is on the fac­tors of pro­duct safe­ty and pro­duct qua­li­ty.
For you as a mar­ket par­ti­ci­pant and user, the new EU re­gu­la­ti­on con­sists of a mix of fa­mi­li­ar con­tent from the pre­vious Di­rec­ti­ve 93/42/EEC and far-rea­ching ch­an­ges. Among the es­sen­ti­al, sub­stan­ti­ve and pro­ce­du­ral con­tent for you and your in­dus­try are the fol­lo­wing con­tents of the Brussels Regulation:

Ru­les for the clas­si­fi­ca­ti­on of me­di­cal de­vices
New terms and ru­les lead to ch­an­ges in the as­sign­ment of exis­ting pro­ducts to par­ti­al­ly mo­di­fied pro­duct clas­ses. For ex­am­p­le, the­se ch­an­ges af­fect the pro­duct ran­ge of “Stand-alo­ne software”.

Con­for­mi­ty eva­lua­ti­on pro­ce­du­re
Fol­lo­wing the set of ru­les for clas­si­fi­ca­ti­on, the con­for­mi­ty as­sess­ment pro­ce­du­re now also va­ries de­pen­ding on the class.

Tech­ni­cal Documentation/Document Ma­nage­ment Sys­tem
The tech­ni­cal do­cu­men­ta­ti­on ac­cor­ding to Me­di­cal De­vice Re­gu­la­ti­on pro­ves to be much more de­tail­ed. Be­ne­fits of con­trol and do­cu­men­ta­ti­on for the com­pa­nies be­co­me clear when loo­king at the new un­der­ly­ing ta­bu­lar sche­me in de­tail. The sub­di­vi­si­on into in­di­vi­du­al ca­te­go­ries in a di­rect link with the as­so­cia­ted de­tail­ed re­qui­re­ments forms the ba­sis for a de­tail­ed tech­ni­cal documentation.

Cli­ni­cal evaluations/clinical tri­als
Si­gni­fi­cant­ly in­creased re­qui­re­ments cha­rac­te­ri­ze this ac­tion item. This ap­pli­es in par­ti­cu­lar to high-risk pro­duct groups.

Com­pa­ny responsibility/safety of­fi­cer
A si­gni­fi­cant ch­an­ge for your com­pa­ny re­sults from the re­qui­re­ment of the EU bo­dies for a re­spon­si­ble per­son in their or­ga­niza­ti­on to be ac­coun­ta­ble for re­gu­la­to­ry compliance.

Qua­li­ty ma­nage­ment
The FDA Me­di­cal De­vice 21 CFR 820 (FDA = U.S. Food and Drug Ad­mi­nis­tra­ti­on) sti­pu­la­tes the re­qui­re­ments for ma­nage­ment sys­tems of me­di­cal de­vice ma­nu­fac­tu­r­ers. In this func­tion, De­vice 21 CFR 820 is the coun­ter­part to ISO 13485. The core re­qui­re­ment is that pro­ce­du­ral in­s­truc­tions such as do­cu­ment con­trol, pro­cu­re­ment, de­ve­lo­p­ment and pro­duc­tion are do­cu­men­ted and im­ple­men­ted analogously.

Mar­ket sur­veil­lan­ce me­cha­nisms
In par­ti­cu­lar, the man­da­to­ry use of the EUDAMED da­ta­ba­se pro­vi­des grea­ter trans­pa­ren­cy. It is available to both the pu­blic and di­rect com­pe­ti­tors as an in­for­ma­ti­on me­di­um. The cha­rac­te­ristics of each me­di­cal de­vice are map­ped by me­ans of ap­pro­pria­te links. Sup­p­ly chain tracea­bi­li­ty is also possible.

Ways to comply with the Medical Device Regulation

To fa­sci­li­ta­te ti­me­ly com­pli­ance with the new re­gu­la­ti­on, you are cal­led upon to act, if you hold a re­spon­si­ble po­si­ti­on in your com­pa­ny. A co­her­ent plan for the tran­si­ti­on of your com­pa­ny to the Me­di­cal De­vice Re­gu­la­ti­on, both in terms of time and con­tent, is a pre­re­qui­si­te for your suc­cess. High prio­ri­ty should be gi­ven to the life cy­cles of your me­di­cal de­vice port­fo­lio. Exis­ting MDD cer­ti­fi­ca­ti­ons will lose their va­li­di­ty on May 26, 2024, ac­cor­ding to EU re­gu­la­ti­ons. Plea­se note in your plan­ning that your pro­ducts al­re­a­dy cer­ti­fied ac­cor­ding to MDD must also com­ple­te the new con­for­mi­ty pro­cess to be es­tab­lished ac­cor­ding to MDR. A pro­tec­tion of the “grand­fa­ther sta­tus” is not guaranteed.

In the tran­si­ti­on pha­se, you are par­ti­cu­lar­ly chal­len­ged in your func­tion as a ma­nu­fac­tu­rer or pro­vi­der. The hig­hest prio­ri­ty is to de­si­gna­te and train the per­son re­spon­si­ble for re­gu­la­to­ry com­pli­ance in your fa­ci­li­ty (MDR Ar­tic­le 15). Up­dates to in­ter­nal qua­li­ty assu­rance pro­ce­du­res, do­cu­men­ta­ti­on, and mo­di­fied pro­duct clas­si­fi­ca­ti­on are mandatory.

Against this back­ground, the fol­lo­wing stan­dar­di­zed pro­ce­du­re ac­cor­ding to the fol­lo­wing 4 points is recommended:

  • Im­ple­men­ta­ti­on of the con­for­mi­ty eva­lua­ti­on re­la­ted to the product
  • Com­ple­ting a de­cla­ra­ti­on of conformity
  • “CE” mar­king of the products
  • Re­gis­tra­ti­on of com­pa­ny and pro­ducts in the EUDAMED database.

Conclusion and criticism of the new regulation

With the MDR, EU of­fi­ci­als have set out to crea­te a con­tem­po­ra­ry, uni­form so­lu­ti­on for qua­li­ty ma­nage­ment and mar­ket re­lease of me­di­cal de­vices. Gre­at at­ten­ti­on is paid to the qua­li­ty and safe­ty of pro­ducts. Per­haps you also be­long to the group of small and me­di­um-si­zed com­pa­nies in the me­di­cal tech­no­lo­gy sec­tor that fear over-re­gu­la­ti­on by the ex­ten­si­ve set of re­gu­la­ti­ons and ad­di­tio­nal au­di­ting bodies?

Espe­ci­al­ly the as­sess­ment of the con­for­mi­ty by the “com­pli­ance ma­na­ger” to be na­med could re­sult in a staf­fing is­sue, at first. In a case of hard­ship, a shorta­ge of cer­ti­fied au­di­tors could de­lay the cer­ti­fi­ca­ti­on nee­ded for mar­ket re­lease. Me­di­cal tech­no­lo­gy in­dus­try as­so­cia­ti­ons ex­press fe­ars that a bot­t­len­eck in cer­ti­fi­ca­ti­ons could have a ne­ga­ti­ve im­pact on the mar­ket launch of in­no­va­ti­ve and mar­ke­ta­ble products.

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The EU GMP gui­de­line sum­ma­ri­zes all re­gu­la­ti­ons and ope­ra­ting in­s­truc­tions that have ever been spe­ci­fied for phar­maceu­ti­cal com­pa­nies in the Fe­de­ral Re­pu­blic of Ger­ma­ny. This


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