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Once an Easy Path, Europe’s Regulatory Approval Toughens

Not long ago, orthopaedic companies navigated Europe’s regulatory approval process before any other country due to the ease of requirements. Medical device companies say that it’s significantly more difficult to obtain CE Marking now, and will continue to be so as the Medical Device Regulations (MDR) are enacted, according to Emergo’s Global Medical Device Industry Outlook for 2017.

More than 1,700 medical device quality and regulatory affairs professionals worldwide took Emergo’s latest survey. They were asked, “Based on your experience, do you think the current process of obtaining regulatory approval for a medical device or IVD in these markets is easier or more difficult than it was a few years ago?” In the 2016 survey, 35% of respondents said that Europe’s approval process had gotten more difficult. In 2017, that number jumped to 61% of respondents. The results also indicated that China remains the most difficult market to enter, due to the onslaught of new regulations released in recent years.

What did industry have to say about other countries significant for orthopaedics? The results are depicted below.

Based on your experience, do you think the current process of obtaining regulatory approval for a medical device or IVD in these markets is easier or more difficult than it was a few years ago?

RegulatoryApprovalSurveyResults

The final draft of the MDR was published in February and is expected to be voted on in March, setting compliance for 2020. More stringent clinical data and postmarket reporting requirements, upclassification of devices and increasing demands on and by Notified Bodies have and will continue to make CE Marking more difficult to obtain and maintain, a point stressed by Emergo and other regulatory agencies.

At OMTEC 2017, Emergo’s Vice President of Global Regulatory Affairs, Evangeline Loh, Ph.D., will provide a global regulatory outlook, including a review of MD. Representatives from TÜV SÜD and BSI will also speak on MDR and ISO 13485, respectively.

 

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