The correct route for the confor­mity assess­ment proce­dure depends on the valid legal basis for medical devices. Currently, two EU regu­la­tions are in force, as there is a tran­si­tional period until the new EU Medical Device Regu­la­tion comes into appli­ca­tion. Up to 25 May 2021, the EU Medical Devices Direc­tive 93/42/EEC is still applic­able. Beyond this date, certi­fied and regis­tered medical devices can still be sold for 4 years without the manu­fac­turer being allowed to make rele­vant changes.

The Euro­pean Regu­la­tion on Medical Devices (MDR) 2017/745 and 2017/746 on in-vitro diag­nos­tics will apply with the cut-off date of 26 May 2021. If a Noti­fied Body is already desig­nated for certi­fi­ca­tion proce­dures according to MDR and a contrac­tual rela­tion­ship exists between this body and a manu­fac­turer, CE-certi­fi­ca­tion according to the Medical Devices Regu­la­tion can take place. Accord­ingly, manu­fac­turers can currently carry out confor­mity assess­ment between two Euro­pean legal frameworks.

However, the neces­sary require­ments do not differ signif­i­cantly. The require­ments to be fulfilled are termed Essen­tial Require­ments in the MDD (Annex I), whereas the MDR describes them as Essen­tial Safety and Perfor­mance Require­ments (cf. Annex I). Every manu­fac­turer must fulfil these for their medical devices! The respec­tive confor­mity assess­ment proce­dures (MDD Annexes II-VI; MDR: Annexes IX-XI) deter­mine which further aspects must also be consid­ered. The choice for the appro­priate proce­dure depends on the clas­si­fi­ca­tion of the medical device. The following figure shows the options avail­able to medical device manufacturers.

After a successful confor­mity assess­ment proce­dure, the manu­fac­turer can issue a decla­ra­tion of confor­mity and sign the respec­tive device with a CE marking according to Annex XII (MDD) or Annex V (MDR).

If you would like to find the right confor­mity assess­ment proce­dure for your medical device, please contact us! We are happy to support you!!

If you wish, we can accom­pany you through the entire certi­fi­ca­tion process. You set the pace and the type of cooperation!

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