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).
Medical Device Single Audit Program (MDSAP) Frequently Asked Questions - Certified once, recognized globally
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. Download Now
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.
Device Classification Under MDD 93/42/EEC, LRQA is a notified body for medical devices using the quality system conformity routes – Annexes II and V. Our field-based Account Managers, together with our product conformity team, offer support and guidance.
Are you prepared for the changes?
For many IVD products the manufacturer can self-declare that their products comply with the IVD Directive and place their product on the European market with a CE mark. However, for products listed in Annex II, List A or products for self-testing, notified body certification is required.