With the new IVDR expected to be published in Q2 2017, regulatory affairs professionals and device manufacturers are now seeking clarification on how to implement the new requirements within their organizations.
Do you have questions around the new MDR expected to be published in Q2 2017? Regulatory affairs professionals and device manufacturers are looking for answers and solutions on how to implement the new requirements.
This interview is the first of a two-part series where Susan Mecca, LRQA Technical Manager, Medical Devices, shares her thoughts on the new ISO 13485:2016 medical quality management system (QMS) standard, and how it impacts manufacturers.
Overview of ISO 13485:2016 (Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes)
The new IVD Regulation (IVDR) will require sampling of technical files for review by a Notified Body for devices classified as B or C under the regulation.
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.
While waiting for the publication of the new regulation, which is expected in Q1 2017, medical device and IVD manufacturers are still subject to random unannounced factory inspections by Notified Bodies at least once every three years.
Under the existing IVDD, approximately 80% of IVD manufacturers are self-certified and do not require Notified Body involvement. The new IVDR comes with new classification rules which will in the near future require about 80% of IVD manufacturers to require some form of Notified Body involvement, a four-fold increment from before.
In this 20 minute webcast, Susan Mecca, Senior Technical Manager, Medical Devices - LRQA Americas, will provide practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016, particularly those around Risk Management and the Interconnection with other Regulatory Requirements to the corresponding Medical Device Directives (MDD) and In Vitro Diagnostic Medical Devices (IVDD).
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