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Conference highlights new Medical Device and IVD regulations

By Hart Bio | 27th February 2020
Conference highlights new Medical Device and IVD regulations Image

Two members of the Hart Biologicals QA team have attended the 3rd Annual European Medical Device and Diagnostic Quality Management Conference in Brussels.

Jennifer Feasby, Quality Manager, and Jenny Leach, Regulatory Affairs Officer attended the meeting with officials from across Europe and learned more about new regulations that will have an impact on the UK based company. 

The conference, which was held in the Belgian capital, was aimed at building excellence in quality management and featured attendees from 150 MedTech companies to focus on product quality and supplier quality management. 

Jenny Leach said: “It was a great to be surrounded by other like-minded, quality professionals that re-affirmed our strategy for becoming IVDR compliant. 

“Overall, I found the conference a very insightful and beneficial experience.” 

Hart Bio were given the opportunity to be part of highly interactive sessions supported by real-life business examples; case studies, Q&A sessions, panel debates and interactive workshops led by experienced Product Quality and Supplier Quality professionals. 

Jennifer Feasby said: “The event highlighted the impact of the updated EU MDR and IVDR, and the responsibilities of the PRRC (Person Responsible for Regulatory Compliance), global quality management strategies and setting up collaborations with critical suppliers. 

“All of this will ensure Hart Biologicals is ready for the significant changes to legislation coming into effect.” 

MedTech quality management professionals throughout Europe are looking to evolve with the new Regulation requirements, ensuring teams are prepared for these changes. 

In order to achieve compliance in global MedTech markets, product quality and supplier quality management professionals must comply with other global regulatory agencies.  

Jennifer continued: “We attended the Q&A session with Ir. Bart Mersseman – Global Certification Manager for Notified Body SGS Belgium, and Marta Carnielli IVD Technical Officer at TÜV SÜD GmbH, about the expectations of notified bodies to ensure product quality. 

“This called attention to the requirements for an increase in post-market surveillance, the requirements involved in assigning a PRRC and the changes in product labelling and supply chain organisation. 

“We already have plans in place to make these changes; we are now reassured that the changes we are making, are the correct ones, and have learnt best practices that will allow the changes to be completed in time for the deadline of May, 2022.” 

Meetings took place at the conference with MedTech quality management teams to unearth innovative ideas that will allow for better execution and maintenance of effective quality management processes. 

The conference has led to actionable takeaways for further improving quality management processes to achieve corporate goals. 

Find out more about Hart Biological’s Quality Assurance team here: