On Friday May 5, 2017, the final texts of the new European Medical Device (MDR) and In Vitro Diagnostic Device (IVDR) Regulations were published in the Official Journal of the European Union. This milestone sets in motion the timeline for implementation of the new regulations, which comes into force on May 25, 2017, being twenty days after the publication.
“This is a significant landmark and a welcome development,” said Nick Baker from leading professional assurance services organization, LRQA. “The MDR has a transition period of three years and will replace the current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). The IVDR has a transition period of five years and will replace the IVD Directive (98/79/EC). Manufacturers will need to update their technical documentation and processes in order to meet the requirements of the new regulations.”
The final text for MDR can be found here and for the IVDR, this can be read here.
As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA is actively shaping the medical regulations and associated harmonized standards through our experts’ participation in the Medical Device Regulations (MDR) and In Vitro Diagnostic Device Regulations (IVDR) technical committees and associations, such as European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA). We also provide input to regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for the development of regulatory policies. LRQA is currently working towards having a full scope as a Notified Body under the new regulations.
With the stated transition timelines of three years for medical device manufacturers and five years for IVD manufacturers, LRQA has a range of assessment and training services designed at helping organizations serving the medical arena transition to the revised regulations as seamlessly as possible.
Contact us to learn more about Medical Devices Regulation (MDR) and IVDR