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MDR

Medical Devices Regulation

Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). In 2017 two new regulations – one on medical devices and the other on in vitro diagnostic medical devices entered into force. The Medical Devices Regulation (MDR) replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMD). The In vitro diagnostic Medical Devices Regulation (IVDR) replaces the In Vitro Diagnostic Medical Devices Directive (IVDMD). As of May 2017, this new European legislation is in force and applies to all medical device manufacturers who intend to place their products in the European Union (EU).

The new rules will only fully apply after a transitional period. Based on the adoption of the amendment to postpone the application of the MDR by 1 year (European Commission, 23 April 2020), that period lasts for 4 years (instead of 3) after the entry into force of the MDR (i.e. until May 2021). This postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. For the in vitro diagnostic medical devices the transitional period is 5 years after the entry into force of the IVDR (i.e. until May 2022).

The aim of the MDR and IVDR is to increase patient safety and to ensure that innovative medical devices remain available to patients.

The legislation will significantly increase the regulatory and liability burden for manufacturers and suppliers of these products. Most Life Sciences companies face very challenging timelines to comply with this legislation: by May 2021 for general medical devices, and by May 2022 for in vitro diagnostic medical devices.

The key changes of the MDR/IMDR

  • Wider scope of regulated medical devices
  • More stringent clinical evidence and documentation
  • Increased focus on identification and traceability
  • Definition of common specification
  • Unannounced factory audits
  • Increased Notified Body authority and/or involvement
  • More rigorous vigilance and market surveillance
  • At least one person responsible for regulatory compliance

Some of the challenges we see

  • Notified bodies situation
  • Software as Medical Device
  • Up-classification
  • Scope of MDR / Definition
  • Contracts
  • New economic operators
  • Product liability
  • Inducement rules

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07 July 2020
On the Pulse
Wel­come to ‘On the Pulse’ de­livered by the Glob­al Life Sci­ences & Health­care Sec­tor Group
20 April 2020
CMS Ex­pert Guide to ad­vert­ising of medi­cines and med­ic­al devices
Are you look­ing for in­form­a­tion on phar­ma­ceut­ic­al ad­vert­ising reg­u­la­tion and med­ic­al device ad­vert­ising? Learn more about it in this CMS Ex­pert Guide.
26 March 2020
European Com­mis­sion pro­poses delay­ing the May 2020 ap­plic­a­tion of the EU...
The European Com­mis­sion has con­firmed it is work­ing on a pro­pos­al to delay for one year the date of ap­plic­a­tion of the new EU Med­ic­al Devices Reg­u­la­tion 2017/745/EU (the “MDR”) in light of the Cov­id-19...
17 June 2020
Pod­cast: Ad­vert­ising of Medi­cines and Med­ic­al Devices
Epis­ode #2 of On the Pulse brought to you by the Glob­al Life Sci­ences & Health­care Sec­tor Group
06 March 2020
MDR - Agree­ments with third party con­tract man­u­fac­tur­ers
The EU Med­ic­al Device Reg­u­la­tion, which comes in­to force on 26 May 2020, will lead not only to big changes in how med­ic­al devices are reg­u­lated, but also to more thought be­ing giv­en to agree­ments between...
07 February 2020
MHRA up­dates guid­ance on with­draw­al of no­ti­fied body ser­vices (UK)
The Medi­cines and Health­care products Reg­u­lat­ory Agency (MHRA) has re­cently is­sued guid­ance for situ­ations where a no­ti­fied body with­draws all, or part, of its ser­vices in re­la­tion to med­ic­al devices....
17 January 2020
New guid­ance on cy­ber­se­cur­ity for med­ic­al devices pub­lished
In Decem­ber 2019, the Med­ic­al Device Co­ordin­a­tion Group (“MD­CG”) is­sued a new guid­ance to help med­ic­al device man­u­fac­tur­ers meet the cy­ber­se­cur­ity re­quire­ments in the Med­ic­al Devices Reg­u­la­tion (“MDR”)...
13 December 2018
Di­git­al Health - The new reg­u­la­tion of med­ic­al soft­ware and apps
The new Med­ic­al Devices Reg­u­la­tion 2017/745 (“MDR”), which comes in­to force in May 2020, rep­res­ents a huge over­haul of the reg­u­lat­ory frame­work gov­ern­ing med­ic­al devices in the EU.  The com­pli­ance...
02 May 2017
New reg­u­la­tion on med­ic­al devices
In­tro­duc­tion The cur­rent leg­al frame­work for med­ic­al devices in the European Uni­on is based on the fol­low­ing Dir­ect­ives, ad­op­ted in the 1990s: §  Dir­ect­ive 90/385/EEC, act­ive im­plant­able med­ic­al...
12 April 2017
EU Med­ic­al Devices Reg­u­la­tion and In-Vitro Med­ic­al Devices Reg­u­la­tion ad­op­ted...
The EU Med­ic­al Devices Reg­u­la­tion and In-Vitro Med­ic­al Devices Reg­u­la­tion (the “Reg­u­la­tions”) were ad­op­ted on 5 April 2017, fol­low­ing a fi­nal vote at the European Par­lia­ment. The Reg­u­la­tions were...