On 30 September and 1 October, GBA Key2Compliance colleagues Emily Malmberg and Maria Nordlinder travelled to Bologna to participate as invited speakers at Complife’s annual MDG Health Matters – Medical Device Governance Forum: Beyond Compliance.
Complife, part of GBA Group, brought together representatives from across the medical device and IVD industry, including the Italian Ministry of Health, several Notified Bodies, manufacturers, customers and representatives from Complife’s European subsidiaries.
The programme combined round-table discussions with more detailed technical sessions. Emily joined the round table “IVDR Focus: Readiness, Evidence and Notified Body Expectations” and contributed to the technical session “Performance Evaluation under IVDR: From Data to Compliance.”
Maria took part in the technical session “Market Access: Comparing EU and Extra-EU Documentation Pathways,” contributing to the discussion on documentation requirements for different markets.
Collaboration as a common theme
One of the strongest messages from the event was the importance of collaboration. Much of the discussion focused on greater harmonisation across countries, authorities and Notified Bodies, as well as the value of meeting and exchanging experiences.
Medical device and IVD regulations are strict, but their interpretation and practical application still require professional judgement. Bringing regulators, Notified Bodies, manufacturers and industry experts together is therefore essential for developing a shared understanding and moving the industry forward.
The discussions also showed that some manufacturers remain concerned about the MDR and, in particular, the IVDR. Even when proposed changes are intended to simplify the regulations, the prospect of further updates can create uncertainty.
Notified Bodies provided clear insights into what they expect to see during their reviews, from qualification and classification to the connection between product claims and clinical performance. AI was another important topic, raising the question of whether Competent Authorities, Notified Bodies and manufacturers will have access to enough specialist expertise to meet the growing needs in this area.
We are pleased that Emily and Maria were invited to contribute to the programme and represent GBA Key2Compliance. Events like this provide valuable opportunities to share expertise, learn from different perspectives and strengthen collaboration across both the industry and GBA Group.