Medical Device Regulation

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

The Ger­man coun­ter­part to the term “Me­di­cal De­vice Re­gu­la­ti­on” is “Me­di­zin­pro­duk­te­ver­ord­nung”. The re­gu­la­ti­on 2017/745 by the Eu­ro­pean Uni­on (EU) will be en­ac­ted on May 26, 2021 across Eu­ro­pe. In this ar­ti­cle pro­vi­des you with in­for­ma­ti­on on the con­tent and im­ple­men­ta­ti­on re­gu­la­ti­ons for the me­di­cal tech­no­lo­gy industry.

EU regulation tailored for the medical technology industry

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 aut­ho­ri­ties agreed upon a se­pa­ra­te re­gu­la­ti­on re­gar­ding the Di­rec­ti­ve 98/79/EU on in-vi­tro dia­gnostics (IVD). This di­rec­ti­ve was not in­clu­ded in the Me­di­cal De­vice Re­gu­la­ti­on. It is re­pla­ced by the se­pa­r­ate­ly draf­ted EU Re­gu­la­ti­on “In-Vi­tro Dia­gnostic Me­di­cal De­vices Re­gu­la­ti­on 2017/746 (IVDR).

Binding from May 26, 2021 across Europe.

In con­trast to the dis­con­ti­nued di­rec­ti­ve, the new EU par­lia­ment re­gu­la­ti­on has gai­ned in in­ter­na­tio­nal pro­fi­le. Its bin­ding va­li­di­ty ex­tends to all EU Mem­ber Sta­tes from 26 May 2021. It must be no­ted here that by Oc­to­ber 2019, no na­tio­nal le­gis­la­ti­on has been pas­sed in the in­di­vi­du­al mem­ber sta­tes. This also ap­p­lies to Ger­man pecu­lia­ri­ties, re­qui­re­ments and pe­nal pro­vi­si­ons to be en­ac­ted. A re­spec­ti­ve draft for a Ger­man im­ple­men­ting law al­rea­dy exists. Howe­ver, the Fe­deral Mi­nis­try of He­alth ex­pects tran­si­tio­nal periods.

Ac­cord­ing to the exis­ting le­gal text, the a tran­si­ti­on pe­ri­od of three ye­ars ap­p­lies for the im­ple­men­ta­ti­on. At the la­test af­ter this dead­line, you as the ma­nu­fac­tu­rer are ob­li­ged to pre­sent an MDR cer­ti­fi­ca­te. Only then you are al­lo­wed to mar­ket a pro­duct for the first time.

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

Objective and necessity of the new EU regulation

Ba­si­cal­ly, the new re­gu­la­ti­on aims at an op­ti­mi­zed, uni­form re­gu­la­ti­on for the mar­ket launch of me­di­cal tech­no­lo­gy pro­ducts. It fo­cu­ses on the fac­tors pro­duct safe­ty and pro­duct qua­li­ty. For you as a mar­ket par­ti­ci­pant and user, the new EU re­gu­la­ti­on pro­vi­des a mix of known con­tent from the pre­vious Di­rec­ti­ve 93/42/EEC and far-reaching chan­ges. For you and your in­dus­try, the fol­lowing main con­tent and pro­ce­du­ral con­tent of the Brussels re­gu­la­ti­on may be of interest:

Re­gu­la­ti­ons on the clas­si­fi­ca­ti­on of me­di­cal de­vices New ter­mi­no­lo­gy and re­gu­la­ti­ons re­sult in a chan­ged as­so­cia­ti­on of exis­ting pro­ducts to par­ti­al­ly chan­ged pro­duct clas­ses. For ex­amp­le, the­se chan­ges af­fect the pro­duct ran­ge of “Stand-alo­ne software”.

Con­for­mi­ty as­sess­ment procedure
Ac­cord­ing to the ru­les for the clas­si­fi­ca­ti­on, the con­for­mi­ty as­sess­ment pro­ce­du­re now va­ries de­pen­ding on the class.

Tech­ni­cal documentation/Document Ma­nage­ment System
The tech­ni­cal do­cu­men­ta­ti­on ac­cord­ing to the Me­di­cal De­vice Re­gu­la­ti­on pro­ves to be si­gni­fi­cant­ly more de­tail­ed. The be­ne­fits of su­per­vi­si­on and do­cu­men­ta­ti­on for com­pa­nies are ob­vious af­ter a de­tail­ed look at the new un­der­ly­ing sche­ma in ta­bu­lar form. The or­ga­niz­a­ti­on into in­di­vi­du­al ca­te­go­ries with a di­rect re­fe­rence to the re­la­ted de­tail­ed re­qui­re­ments is a ba­sis for a de­tail­ed tech­ni­cal documentation.

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 d.velop Life Sciences

Cli­ni­cal evaluations/clinical trials
This ac­tion point is sub­ject to si­gni­fi­cant­ly in­cre­a­sed re­qui­re­ments. This espe­cial­ly ap­p­lies to high-risk pro­duct groups.

Cor­po­ra­te responsibility/Compliance Manager
A si­gni­fi­cant chan­ge for your com­pa­ny re­sults from the EU aut­ho­ri­ties de­man­ding a de­di­ca­ted per­son in char­ge of com­pli­an­ce with re­gu­la­to­ry re­qui­re­ments at your company.

Qua­li­ty management
The FDA Me­di­cal De­vice 21 CFR 820 (FDA = U.S. Food and Drug Ad­mi­nis­tra­ti­on) spe­ci­fies the re­qui­re­ments for ma­nage­ment sys­tems of ma­nu­fac­tu­rers of me­di­cal de­vices. In this func­tion, the De­vice 21 CFR 820 is the coun­ter­part to the ISO 13485. Its main re­qui­re­ment is that pro­cess in­st­ruc­tions and do­cu­ment con­trol, purcha­sing, de­ve­lo­p­ment as well as the pro­duc­tion must be do­cu­men­ted and im­ple­men­ted equivalently.

Mar­ket sur­veil­lan­ce mechanisms
Espe­cial­ly the man­da­to­ry use of the EUDAMED da­ta­ba­se crea­tes grea­ter trans­pa­ren­cy. It is avail­ab­le as a source of in­for­ma­ti­on to the pu­blic as well as for di­rect com­pe­ti­tors. Using re­spec­ti­ve links, every me­di­cal de­vice is dis­play­ed with its cha­rac­te­ris­tics. This also al­lows to re­trace sup­ply chains.

How to comply with the Medical Device Regulation

In or­der to com­ply with the new re­gu­la­ti­on in time, you as the per­son in char­ge at your com­pa­ny must act. A plan with co­he­rent sche­du­le and con­tent of the im­ple­men­ta­ti­on of the Me­di­cal De­vice Re­gu­la­ti­on is the ba­sis of your suc­cess. Your main prio­ri­ty should be the lifecy­cles of your port­fo­lio of me­di­cal de­vices. Ac­cord­ing to the EU di­rec­ti­ve, the exis­ting MDD ap­pro­vals loo­se va­li­di­ty by May 26, 2024. Your plan­ning should con­si­der that your al­rea­dy exis­ting MDD-cer­ti­fied pro­ducts must be sub­ject to the new con­for­mi­ty pro­cess to be es­tab­lis­hed ac­cord­ing to the MDR. A pro­tec­tion of the “grand­f­a­ther sta­tus” is not guaranteed.

In the con­ver­si­on pha­se, you are par­ti­cu­lar­ly chal­len­ged in your func­tion as a ma­nu­fac­tu­rer or sup­plier. Your hig­hest prio­ri­ty should be iden­ti­fy­ing and trai­ning each per­son re­spon­si­ble for the com­pli­an­ce with re­gu­la­to­ry di­rec­ti­ves in your com­pa­ny (MDR ar­ti­cle 15). The qua­li­ty as­suran­ce pro­ce­du­res and the do­cu­men­ta­ti­on must be up­dated and the pro­duct clas­si­fi­ca­ti­on must be modified.

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

  • Im­ple­men­ting the eva­lua­ti­on of the con­for­mi­ty ba­sed on the product
  • Crea­ting the de­cla­ra­ti­on of conformity
  • “CE” mar­king of the products
  • Ent­ry of the com­pa­ny and its pro­ducts in the EUDAMED database.

Conclusion and criticism of the new regulation

With MDR, the EU lea­ders have set out to crea­te a mo­dern, uni­form so­lu­ti­on for qua­li­ty ma­nage­ment and the mar­ket re­lease of me­di­cal de­vices. It main­ly fo­cu­ses on the on the pro­duct qua­li­ty and pro­duct safe­ty. May­be you as a small or me­di­um-si­zed busi­ness in the me­di­cal de­vice in­dus­try also fear to be over-re­gu­la­ted by the ex­ten­si­ve set of ru­les and ad­di­tio­nal con­trol­ling authorities?

Espe­cial­ly the as­sess­ment of the con­for­mi­ty by the “com­pli­an­ce ma­na­ger” to be na­med could re­sult in a staf­fing is­sue, at first. I the worst case, a lack of cer­ti­fied su­per­vi­sors could de­lay the ap­pro­val re­qui­red for the pro­duct launch. In­dus­try as­so­cia­ti­ons in the me­di­cal tech­no­lo­gy sec­tor ex­press fe­ars that a bot­t­len­eck in cer­ti­fi­ca­ti­on could have a ne­ga­ti­ve im­pact on the mar­ket launch of in­no­va­ti­ve and mar­ket­a­ble products.

Discover the suitable software for MDR compliance

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De­fi­ni­ti­on of the term („What is a cor­rec­ti­ve ac­tion?“) The ISO 9000 de­scri­bes a cor­rec­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a

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