Transferring Notified Bodies
Transferring notified bodies is a critical process and a manufacturer should make this decision carefully. Regardless of the reason, both manufacturers and notified bodies must take into account the guidelines governing this process, and for the manufacturer specially, when choosing which notified body to transfer, how this notified body will fit in with his certification plans. To help manufacturers learn about the requirements and give them the tools to understand and make this strategic decision, the webinar will explore the following points:
• The reasons to change Notified Body
• The keys points for a manufacturer to consider before taking the decision to transfer NB and the prerequisites for transferring
• Introduction to the guidelines & the documents governing the transfer process
• Presentation of the technique for transferring a manufacturer’s notified body
• Changing in the labelling
The Clinical Evaluation – Demonstration of clinical safety and performance
Clinical Evaluation is key for the demonstration of the clinical safety and performance of the devices. Why is it so important? This is relevant not only before placing a new device on the market, but it is also expected that the manufacturer will monitor its clinical performance and safety as part of the Quality Management System once the device is commercialized.
• Is the clinical evaluation mandatory for all types of medical devices?
• Why is it so important?
• What is the best methodology to demonstrate and confirm the clinical performance and safety of the device as requested by EU MDD?
• What does the Notified Body look at to assess the clinical evaluation?
• How the process can be part of the Quality management system?
• What are the common mistakes to avoid?
• Will the new MD regulation introduce any new requirements in regards to the clinical evaluation?
The IVD Technical File compilation
Notified bodies and competent authorities use the technical documentation to ensure that the medical device conforms to the applicable regulations, and manufacturers use it as a living reference tool for the device. As a result, ensuring the contents are complete and updated is of utmost importance for a medical device manufacturer to maintain its devices' CE marking. For information about the contents of IVD technical file and what Notified Bodies look for in the technical file submissions, watch this webinar on:
• The requirements of the European Directive 98/79/EC of 27 October 1998 on IN VITRO DIAGNOSTIC MEDICAL DEVICES ("IVDD"),
• The different parts and documents that go into making a technical file,
• The use of the IVD technical file by Manufacturers, Notified Bodies, and Competent Authorities,
• The unique requirements and challenges of IVD technical documentation.
Evolutions in the EU IVD Regulatory Framework
The EU in vitro diagnostic medical device regulatory landscape is changing drastically. The changes of the IVD Medical Device Directive 98/79/EC (IVDD) are expecting to lead to a fully remodeled regulation impacting:
• IVD classification
• Conformity assessments
• Clinical evidence requirements
• New technical specifications, etc....
This webinar covers the major changes that we see coming in the new IVD regulatory framework, as well as a notified body's perspective on what these changes mean for an IVD manufacturer.
Understanding EN ISO 14971:2012
Risk management is a key portion of the medical device lifecycle, from design to discard. It applies to all class of devices regardless of where they are marketed. In the European Union, the Risk Management file is part of the device's technical documentation demonstrating conformance to the Medical Device Directives. As a Harmonized Standard, EN ISO 14971:2012 can be used to demonstrate conformity to the Essential Requirements. It provides manufacturers with guidelines to follow to implement their Risk management process. Changes were made to the informative annexes between the 2009 and 2012 versions of EN ISO 14971 to clarify the link between the European Directives and the Standard requirements. The points covered in the webinar will include:
• The reasons behind the revision
• The changes and relationship between the Standard and the Directives
• The main items to be taken into account to comply with the risk management requirement of the European Directive (using EN ISO 14971:2012)
Controlling Critical Subcontractors in 2014 – Regulatory Evolutions
Recent regulatory evolutions in the EU have prompted manufacturers and notified bodies to take second looks at how medical device manufacturers control their critical subcontractors and crucial suppliers. According to the standard and regulatory texts, not much has changed in the way of requirements. In practice, however, manufacturers may need to make changes to the ways they demonstrate the monitoring of the quality system in operation, including the suppliers and contractors and show that they have integrated the quality system of the critical subcontractors and crucial suppliers with their own quality system.
The webinar will include:
• A description of the requirements for controlling critical subcontractors and suppliers as it stands today,
• Some methods that manufacturers can use to prepare for the Recommendation's specifics.
Future of the IVD Directive: Expected Regulatory Change Based on European Commission
One of our Project Managers Lead Auditors in IVDs, Darren Walsh, has attended the AdvaMed 2011 conference on Tuesday, September 27. Darren has moderated the panel Future of the IVD Directive: Expected Regulatory Change Based on European Commission in room 207B at 9:00 AM. The panelists were Dr. Catherine Holzmann, Ph.D, the IVD Department Manager of GMEDand Dr. Judith Andrews, Ph.D, RAC from Medical Device Consultants, Inc.
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