Dr. Burde is an IVD Product Expert in the In Vitro Diagnostics Notified Body at BSI Healthcare. He joined BSI in 2014 as part of BSI’s expansion of the IVD team to address the growing need for Quality and Technical assessments by the IVD Notified Body in response to the upcoming changes to the European In Vitro Diagnostics Regulation.
Describe a QA initiative you will be focusing on in 2014.
One of the main initiatives for 2014 is preparing for and beginning delivery of the unannounced audits that the European Commission now requires Notified Bodies to perform. IVD manufacturers who market products in Europe under an Annex IV certificate and their critical subcontractors and crucial suppliers are subject to unannounced audits at least every 3 years. This is challenging both for Notified Bodies in terms of resource planning and logistics, and for Manufacturers, who need to put systems in place to be prepared to receive unannounced audits at any time.
How do you see the quality assurance role evolving over the next 5 years?
In order for manufacturers to develop products that comply with the increasing regulatory requirements worldwide, quality assurance will need to become more fully integrated into all business processes. By focusing on quality throughout the product lifecycle, companies will be able to bring higher quality products to market more quickly.
How is your team adapting to changing regulations worldwide?
The anticipated new European In Vitro Diagnostics Regulation will not only result in a significant increase in the number of products requiring examination by a Notified Body, but will also increase the scope of technologies and clinical uses covered. In anticipation of this increase, we have more than doubled the size of the team in 2014, while strategically recruiting team members with the necessary technical expertise to manage the expanded technical scope.
What keeps you up at night?
The new IVD regulation will have a profound impact on the European IVD market. The number of products requiring Notified Body review will increase from what is currently a very limited list to include the vast majority of IVDs. The current draft foresees a 3-year transition period for full implementation. This represents a huge challenge for manufacturers, who will have to review and classify all existing and future products for the European market, and adapt their Quality Systems to be compliant with the regulation. For Notified Bodies, the major issue will be developing the capacity to assess a wide range of new product types and to handle the large number of additional reviews. It will be extremely challenging for everyone involved to accomplish these tasks in three years.
Stefan will be one of the distinguished speakers at the 5th Annual Diagnostic Quality Assurance Conference.