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Devicemakers importing goods for sale in Europe will need to comply with a revised hazardous substances directive if they are deemed “free for circulation on the EU market,” an industry guidance says. Read More
Just over a quarter of adverse incidents reported by devicemakers to the UK’s Medicines and Healthcare products Regulatory Agency in 2012 were submitted online, compared with nearly 90 percent of user-generated reports, the agency says. Read More
Citing continuing confusion among devicemakers regarding borderline products, the UK’s Medicines and Healthcare products Regulatory Agency last month issued guidance clarifying when they qualify as a medical device in the EU. Read More