Today I attended a very informative webinar hosted by British Standards Institute (BSI) on their interpretation of the medical device regulation requirements under Article 117 for drug device combination products marketing in the European Union from 26 May 2021. My objective for attendance was to confirm my understanding of the Article and obtain an interpretation from a reliable source.
The well-presented session satisfied my objectives (thank you BSI), however what I do find very curious is there remains a plethora of promoted webinars, explaining the MDR requirements, still being presented, with large audience attendance. It is quite evident that the medical device industry was certainly not ready for 26 May 2020 and continues not to be ready. This apparent fact does not bode well for healthcare providers and patients.
The medical device industry has had THREE years to review, assess and implement the actions necessary within their organisations to maintain compliance with the regulations. Now, due to the unprecedented ramifications of the ongoing pandemic, the European Commission has granted yet another year until mandatory compliance. It does beggar belief that an industry who directly employs >675,000 individuals with an EU revenue valued at €115 billion and a 5-16% projected sales growth (CAGR 2017-2024) has been this remiss in assuring their products remain marketable.1
As a wife, parent, friend or relative of a possible consumer/patient of EU medical device products, I am not amused.
Profitable, cost effective, life enhancing products might be removed from the market due to a regulatory team’s inability to locate the supporting data or not enough regulatory resource, attributable to antiquated processes and systems or a poorly administered regulatory strategy that is unmanageable.
Those of us in the business of supporting the lifesciences industry are doing our very best to educate clients and potential clients, disseminate accurate information and eradicate the unawareness.
We can help.
Don’t wait in the dark any longer.
Please feel free to contact me or any of my colleagues KimYoung@instem.com