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).

Discover the suitable software for MDR compliance

Sup­port and sim­pli­fy the crea­ti­on and up­dating of your tech­ni­cal do­cu­men­ta­ti­on with our pro­cess-ori­en­ted dos­sier ma­nage­ment, e.g. in the con­text of the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR). Con­form to ISO 13485 MPG and Me­di­cal De­vice Re­gu­la­ti­on (MDR) standards.

Live insight into the GxP-compliant document management system of Digital Life Sciences

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.

Start your digital transformation for MDR compliance with our powerful, modular software solution

Share now!

Subscribe to the newsletter

You want to stay up to date? Then subscribe to our newsletter.

EU GMP guideline

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

eDMS

Elec­tro­nic do­cu­ment ma­nage­ment system