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Improving Performance, Reducing Risk
In vitro diagnostic device quality
Medical Standards and schemes
the Canadian Medical Device Regulations came into force, affecting all organizations represented as the “legal manufacturer” of medical devices (including in-vitro diagnostic devices) currently selling or seeking to sell into Canada through the device licensing system.
The In-Vitro Diagnostic (IVD) Device Regulation is approaching the final stages of the review process before becoming law and is the proposed revision to the existing IVD Directive 98/79/EC.
LRQA provides accredited certification and training services to ISO 13485, the quality management system requirement for manufacturers of medical devices.
We’re designated as a notified body under the medical devices directive for medical devices using the quality system conformity routes laid out in Annexes II, V and VI.
Recognizing that a global approach to assuring the safety of medical device manufacturing would provide tremendous benefit to the industry and the end user, the International Medical Device Regulators Forum (IMDRF) has created a harmonized approach to auditing and monitoring the manufacturing of medical devices.
As with the upcoming In-Vitro Diagnostic (IVD) Device Regulation, the proposed Medical Device Regulation (MDR) is also approaching the final stages of development before becoming law as a Regulation.
In general, we view an exit from the EU as unlikely to have a significant short-term impact on how LR provides services to clients. However, given the extent of the uncertainty about how the process will unfold, we will continue to follow events and keep our clients updated on our view and plans.
The European Council released the final texts of the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) last month.
Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organizations involved in medical device manufacturing.
LRQA’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, LRQA will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) so that LRQA remains as an EU recognized Notified Body for Medical Devices post the UK leaving the EU.
This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share. Find out what the IVDR & MDR Regulations mean to your organization - LRQA presents the top frequently asked questions.
The new EU IVDR will replace and repeal the existing IVD Directive 98/79/EC when it is published, currently expected during the second quarter of 2017. With the aim of tightening and strengthening the approval system for IVDs, the new regulation introduces a number of important changes
Susan Mecca, Senior Medical Technical Manager – Americas, LRQA will be a panelist during the opening keynote address, PERSPECTIVES ON THE EU MDR & DEVELOPING AN IMPLEMENTATION ROADMAP:
LRQA is proud to sponsor RAPS EU MDR/IVDR Virtual Program, these sessions will deliver expert insights into the changes and impact of the Medical Device Regulation and In Vitro Diagnostics Regulation.