BSI Webinar programme will enable you to prepare for changes:
Listen back to our informative webinars
European Harmonization - MDR Requirements and Progress on key Standards and Labelling
There are 400 standards harmonized under the EU Medical Device Directives (AIMD, MDD and IVDD). When the Directives are replaced by the new Medical Devices and IVD Regulations the standards will no longer provide presumption of conformity to the Regulations. This webinar gives an insight into these key changes for your business and how you can start preparing now.
General Safety and Performance requirements of the IVDR
The IVD industry is facing significant change. The new European In Vitro Diagnostic Regulation (IVDR) entered into force on May 25 2017, marking the start of the transition period for manufacturers selling IVD devices into Europe. ALL IVDs need to meet the SPRs; new IVDs and existing CE-marked IVDs will need to comply with these requirements by 26 May 2022. This webinar will discuss the implications of the new IVDR on manufacturers, and highlight some key points of note for manufacturers as they plan for the transition to the new Regulation.
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.