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In vitro diagnostic device quality
Medical Standards and schemes
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.
LRQA is accredited by the SCC to ISO 13485:2016 and ISO 13485:2016 under Canadian Medical Device Conformity Assessment System (CMDCAS) requirements and is recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) in accordance with the requirements of Q90R0 Policy on CMDCAS.
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.
The decision marks an important milestone for the FDA and is another step towards the global harmonisation of regulatory requirements in the medical devices sector.
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.
Download the on-demand presentation with Susan discussing how to implement and maintain ISO 13485:2016 in order to help manufacturers ensure a successful transition to the revised standard.
Following an update previously released by UKAS, medical device manufacturers need to transition to the revised version of ISO 13485 by 31 March 2019. Considering that this deadline is fast approaching, medical device manufacturers have to plan and implement their transition. Lloyd’s Register (LR) is delivering a webinar on implementing and maintaining ISO 13485:2016 to help manufacturers ensure a successful implementation.
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