Overview of changes & priorities initiated by the new MDR and IVDR requirements
The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC and In Vitro Diagnostic Device (IVD) Directive 98/79/EC. Both Regulations are currently in their final stage of development and are expected to be published towards the end of Q1 2017.
During these webinars, experts from LRQA discuss the current status of the new Regulations, the transition period for manufacturers and the expected ‘Entry into Force’. The webinars offer a comprehensive overview of the key changes which will affect all Medical Device and In-Vitro Diagnostic Medical Device manufacturers, as well as the priorities for the different authorities.
As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA is actively shaping the medical directives and associated harmonised standards through our experts’ participation in the Medical Device Directive (MDD) and In Vitro Diagnostic Device Directive (IVDD) technical committees and associations, such as European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA).
LRQA also provides input to regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA) the UK which reflect the concerns of our clients. LRQA is currently working towards having a full scope as a Notified Body under the new MDR and IVDR.