You are a med­ical device man­u­fac­tur­er and have CE marked your prod­ucts under the Med­ical Devices Direc­tive 93/42/EEC (MDD) or the Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD)? Then you must tran­si­tion to the MDR in the future to keep your prod­ucts on the Euro­pean mar­ket. Below you will find a brief syn­op­sis of the 12 most impor­tant changes includ­ing links to guid­ance and templates.

1. Shift from pre-approval to a life-cycle approach

The MDR pro­motes a shift from pre-approval to a life-cycle approach. Risk man­age­ment and the con­nect­ed process­es on PMS and clin­i­cal eval­u­a­tion must be con­duct­ed con­tin­u­ous­ly through­out the product’s life cycle.

2. Clas­si­fi­ca­tion changes

As men­tioned above, some clas­si­fi­ca­tion rules are new or amend­ed while oth­ers remain unchanged.
Please see here for an overview of the MDR clas­si­fi­ca­tion rules.

3. Change in con­for­mi­ty assess­ment rules

The annex struc­ture of the MDR is dif­fer­ent com­pared to the MDD. Man­u­fac­tur­ers must make sure that they choose the appro­pri­ate con­for­mi­ty assess­ment pro­ce­dure.
Please see here for an overview of the MDR con­for­mi­ty assess­ment routes.

4. Super­vi­sion

The MDR brings a stronger super­vi­sion of Noti­fied Bod­ies by nation­al author­i­ties. Noti­fied Bod­ies in turn will gain more pow­ers to scru­ti­nize man­u­fac­tur­ers. In gen­er­al, man­u­fac­tur­ers of all class­es of devices must pre­pare them­selves for tighter con­trol.
Please also read our arti­cle “Noti­fied Body Selec­tion and Change”.
You are wel­come to con­tact us should you require our sup­port to iden­ti­fy your Noti­fied Body.

5. Clear­er rights and respon­si­bil­i­ties for eco­nom­ic operators

With the MDR roles of eco­nom­ic oper­a­tors (man­u­fac­tur­er, autho­rized rep­re­sen­ta­tive, dis­trib­u­tor, importer) have been nar­row­ly defined. Each eco­nom­ic oper­a­tor must ensure that the cor­re­spond­ing role is ful­ly under­stood and agree­ments are set up accord­ing­ly.
Please vis­it our Down­load Sec­tion for the fact­sheets issued by the Euro­pean Com­mis­sion. 

6. Traceability/ EUDAMED

The MDR requires man­u­fac­tur­ers of all class­es to imple­ment a UDI sys­tem for enhanced trace­abil­i­ty. UDI com­po­nents will also be used for the reg­is­tra­tion in the new upgrad­ed EUDAMED data­base. EUDAMED will replace nation­al reg­istries that have been oper­at­ed under the MDD.
For guid­ance issued by the Euro­pean Com­mis­sion on these top­ics, please vis­it its website.

7. Gen­er­al Safe­ty and Per­for­mance Require­ments (SPR)

The new Gen­er­al Safe­ty and Per­for­mance Require­ments (SPR) will replace the Essen­tial Require­ments (ER). The SPR are much more com­pre­hen­sive than the for­mer ER and also bring new require­ments, e.g. on soft­ware or amend­ed require­ments, e.g. on label­ing. In addi­tion, man­u­fac­tur­ers are required to com­plete the cor­re­spond­ing check­list in much more detail.
You find a pre­view of a SPR check­list in our Sup­port­ive Infor­ma­tion Sec­tion for the MDR.

8. Clin­i­cal evidence

The expec­ta­tions for clin­i­cal eval­u­a­tions under the MDR have been syn­chro­nized for the biggest part with what has already been for­mu­lat­ed in the MEDDEV 2.7/1, rev. 4 guid­ance doc­u­ment. This also means that it will gen­er­al­ly be more dif­fi­cult for man­u­fac­tur­ers to claim equiv­a­lence with anoth­er device. As a result, man­u­fac­tur­ers should con­sid­er gen­er­at­ing their own clin­i­cal data to pro­vide suf­fi­cient clin­i­cal evi­dence.
Please see here for the cor­re­spond­ing MEDDEV doc­u­ment
and our tem­plate for clin­i­cal eval­u­a­tions.

9. Tech­ni­cal File structure

Annex II and III of the MDR pro­vide details about the required con­tents of a Tech­ni­cal File. Noti­fied Bod­ies and com­pe­tent author­i­ties made clear that they expect manufacturer’s doc­u­men­ta­tion to be pre­pared read­i­ly search­able and in line with the revised struc­ture.
You find a pre­view of Tech­ni­cal File check­lists in our Sup­port­ive Infor­ma­tion Sec­tion for the MDR.

10. Per­son Respon­si­ble for Reg­u­la­to­ry Compliance

Man­u­fac­tur­ers must employ a per­son in their orga­ni­za­tion who is in charge of the company’s reg­u­la­to­ry com­pli­ance. This per­son has to pos­sess a defined set of qual­i­fi­ca­tions or expe­ri­ence respec­tive­ly.
Please see here for the cor­re­spond­ing Guid­ance Document.

11. Lia­bil­i­ty

Man­u­fac­tur­ers are required to pro­vide suf­fi­cient finan­cial cov­er­age for poten­tial lia­bil­i­ty claims. The EU Autho­rized Rep­re­sen­ta­tive will become liable for the manufacturer’s prod­ucts as well. 

12. Own Brand Label­ing (OBL)

The con­cept of OBL will be obso­lete under the MDR as there will no more dif­fer­ence between the Orig­i­nal Equip­ment Man­u­fac­tur­er (OEM) and the OBL com­pa­ny. 
We rec­om­mend our arti­cle OEM – Pri­vate Label­ing.

Source: MDR

Do you require fur­ther assis­tance in your tran­si­tion process? 

Please have a look at our Library.
Read our in-depth infor­ma­tion on page “MDR”.
Or get in touch with us direct­ly for fur­ther advice.