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Roles and responsibilities in the Medical Device and IVD Regulations
The new Medical Device and In-Vitro Diagnostic Regulations are expected to be adopted in the first half of 2017. Within the new Regulations articles 10-15 outline the roles and responsibilities of the various actors involved in the manufacture and supply of products into Europe.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will outline the actions required, for each of the roles outlined in the new Regulations.
Post Market Surveillance and Vigilance - do you know the requirements?
The new Medical Device Regulation is expected to be adopted in the first half of 2017. The Regulation contains significant changes in requirements in the post-market area, including PMS planning and implementation, vigilance reporting and handling field safety corrective actions.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will allow you to start planning how to meet the new requirements in this area.
The role of the Person Responsible for Regulatory Compliance under the future Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
The new Medical Device and In Vitro Diagnostic Regulations will be published in the coming months. One of the novelties introduced as part of this major regulatory change in Europe is the concept of the Person Responsible for Regulatory Compliance. This was inspired by the pharmaceutical “Qualified Person” role and has been dramatically reviewed and diluted down since the original draft regulation proposal. However, the basic principles remain.
This webinar will discuss the concept of the Person Responsible for Regulatory Compliance as described in the current draft version of the Medical Device Regulation and the IVD Regulation, provide a brief background on the Pharma Qualified Person duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement for manufacturers.
The In Vitro Diagnostic Regulation - Changes to the IVD regulatory landscape
The upcoming changes to the regulatory requirements for IVDs will require a thorough understanding from manufacturers to ensure a smooth transition from the IVD Directive to the IVD Regulation. Robust and timely plans should be made, and to do so, manufacturers need to be aware of the magnitude of changes and the activity that lies ahead.
This webinar discussed the key requirements that IVD manufacturers will need to be aware of, highlighting the areas that are most changed vs. the current IVD Directive. There is an explanation of the current position and expected timelines, and acknowledgement of the role of the Notified Body, with emphasis on the next steps for manufacturers.
The new revision of MEDDEV 2.7.1 Revision 4: Key changes and clarifications
Revision 4 of the MEDDEV guidance document 2.7.1 - Clinical Evaluation: A guide for manufacturers and notified bodies under Directive 93/42/EEC and 90/385/EEC - was released by the European Commission on 1st July 2016. This document provides information to manufacturers on conducting a clinical evaluation, including demonstration of scientific validity of your data and conclusions.
This webinar will explore the key changes in the new Revision, discussing the new requirements and noting the main clarifications within the guidance document. It will highlight the areas for you to be aware of and consider when conducting clinical evaluations.
Medical Device Regulation: Impact on manufacturer resources
The impact of the upcoming regulatory changes for manufacturers must be clearly understood, and robust, timely plans should be put in place to ensure a smooth transition over the next three years. The change will impact not only Quality and Regulatory functions, but also Operations, Marketing, and Strategic Planning. Manufacturers are encouraged to understand the changes and the impact on their business, to ensure they are fully prepared to begin their transition as soon as possible, minimising the possibility of delays in getting certified under the new Regulation.
This webinar discussed the implications of the new MDR on manufacturer’s resources, and highlight some key points of note for manufacturers as they plan for the transition to the new Regulation.
Update on the EU MDR
What will companies need to be aware of, and when will changes impact them? All medical device manufacturers must plan and prepare for the new Regulation because EU law does not allow grandfathering of devices, so every device manufacturers make must comply with the new requirements aligned with the transition time frames proposed.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar outlines the new requirements so that medical device manufacturers can start planning their resources to ensure uninterrupted CE Marking and EU market access during and after the transition period of the new Regulation.
Will your product be reclassified under the new MDR?
As a result of the current proposals, some devices will be reclassified into a higher risk category. For these devices, the scrutiny of the technical documentation by the Notified Body will increase considerably. It is therefore necessary for manufacturers with devices impacted by this change to be prepared and be aware of the implications of this regulatory change on their technical documentation and placing of the product on the market.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements.