BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow

There is not much demand currently for testing against the EU's Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?

Despite being designated under the MDR in January this year, BSI, one of Europe’s largest medtech notified bodies, has only issued one certificate under the MDR so far. It does not expect to issue more than ten by the year end.

The vast majority of EU medtech companies are instead seeking renewal under the current medical device directives, Gary Slack, senior...