reusch­law Update – 360° Com­pli­ance for Medi­cal Devices


Date 27.05.2024, 08:00-09:30

Ano­ther date for the event

For tho­se inte­res­ted from the Ame­ri­cas, we have ano­ther date on the fol­lo­wing date
  May 28, 2024, 05:00–06:30 PM (CET) 

The Euro­pean Eco­no­mic Area is an attrac­ti­ve sales mar­ket and dis­tri­bu­ti­on tar­get for medi­cal devices and IVDs. The MDR and IVDR pro­vi­de a stan­dar­di­zed set of regu­la­ti­ons that reflect the spe­cial requi­re­ments for medi­cal devices and IVDs. Howe­ver, the con­for­mi­ty of pro­ducts with the requi­re­ments of MDR and IVDR is only the obvious start­ing point. Medi­cal devices and IVDs very often also need to satis­fy fur­ther regu­la­to­ry requirements.Legislation as part of the Euro­pean Green Deal has signi­fi­cant­ly tigh­ten­ed exis­ting requi­re­ments or imple­men­ted new regu­la­ti­ons, inclu­ding the REACH Regu­la­ti­on (PFAS requi­re­ments), the RoHS Direc­ti­ve, the Ecode­sign Direc­ti­ve, the Green Claims Regu­la­ti­on, the Bat­tery Regu­la­ti­on, and pack­a­ging regu­la­ti­ons, to name but a few. Digi­tal pro­ducts or tho­se with AI com­pon­ents must also meet cyber­se­cu­ri­ty requi­re­ments and the requi­re­ments of the AI Act. 

This web­i­nar is a joint event orga­ni­zed by MT Pro­medt Con­sul­ting and reusch­law. MT Pro­medt Con­sul­ting pro­vi­des an update on the ser­vices of an EC REP and the les­sons lear­ned from the per­spec­ti­ve of the EC REP in deal­ing with the requi­re­ments of the MDR and IVDR sin­ce their ent­ry into force. reusch­law addres­ses fur­ther regu­la­to­ry requi­re­ments for medi­cal devices and IVDs which are not gover­ned by the MDR and IVDR and not cover­ed by an EAR but obli­ga­to­ry for their mar­ke­ta­bi­li­ty in the Euro­pean Eco­no­mic Area.

Ses­si­on 1: EU Regu­la­to­ry Frame­work – the full sca­le for medi­cal devices
Spea­k­er: Miri­am Schuh, Head of Health­ca­re, reuschlaw

  • Euro­pean regu­la­ti­on over the enti­re pro­duct life cycle
  • Digi­tal pro­ducts, digi­ta­liza­ti­on, AI Act
  • Pro­duct lia­bi­li­ty, lia­bi­li­ty risks for eco­no­mic operators

Ses­si­on 2: MDR and IVDR – Les­sons lear­ned from an EC REP per­spec­ti­ve
Spea­k­er: Cle­mens Mohr, Head of Euro­pean Aut­ho­ri­sed Repre­sen­ta­ti­ve, MT Pro­medt Con­sul­ting GmbH

  • Tech­ni­cal docu­men­ta­ti­on under MDR and IVDR
  • Manufacturer’s vigi­lan­ce obligations
  • EC REP vs. UKRP vs. CH REP

Par­ti­ci­pa­ti­on for cli­ents, SMEs, indus­try etc. is free of char­ge. Par­ti­ci­pa­ti­on as an exter­nal con­sul­tant is sub­ject to a fee. We char­ge a net fee of €599 for par­ti­ci­pa­ti­on in the event, paya­ble within 14 days of regis­tra­ti­on. If you would like to par­ti­ci­pa­te as an exter­nal con­sul­tant, plea­se cont­act

Regis­tra­ti­on is closed


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