How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.

The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.

Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.

The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.

Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.

Join us for this free, 90 minute webinar presented by our guest Richard Young, Managing Director at Acclaim Biomedical Consultants, where he will be sharing will you in detail what all the significant changes are and how you can begin preparing for compliance now.

Specifically, you will learn:

• Why the European regulations are changing

• What does the new regulation mean for IVD manufactures

• How to classify your IVD using the new risk-based classification system
• How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
• An overview of all the most significant changes brought by the IVDR
• What IVD manufactures can do to start preparing now

   

*Note: Limited live seats available.

Who should attend? 

• In Vitro Diagnostics Executives and CEOs

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Clinical Affairs Professionals and Management 

• R&D Engineers and Management

About the presenter:

This webinar is being lead by Richard Young, founder and managing director at Acclaim Biomedical Consulting Ltd. 

Richard has worked in the Medical Device and In Vitro Diagnostic markets for over 25 years with a personal focus on regulatory compliance, process validation and risk management.

Richard has been an active member of many groups through his time in industry, including representing industry in the formation of the “beyond compliance initiative” and spending many years on the Eucomed Standards Focus Group as well as standards groups such as LBI 35.

Over the last few years, his consulting activities have included a large proportion of training and education including teaching at Sheffield Hallam University in the UK on a Post Graduate Diploma Course.