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Improving Performance, Reducing Risk
Medical quality management
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.
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.
LRQA's Medical Devices experts recently spoke at The Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence. This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share.
Learn how compiling and maintaining product Technical Files/Design Dossiers in accordance with the European regulatory requirements can be administered while launching safe medical devices into the market in a timely and compliant manner.
Connect with us at The Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.