The EU declaration of conformity is usually the shortest document in a medical device file, and it is often the
When Regulation (EU) 2017/745 (MDR) started to apply on 26 May 2021, it brought in Rule 11, a classification rule
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and
Regulation (EU) 2017/745, the Medical Device Regulation (MDR), was adopted on 5 April 2017 and has applied since 26 May
In the United States, section 513 of the Federal Food, Drug, and Cosmetic Act sets a risk-based system of three
Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the
Summary CE marking has long been associated with medical devices placed on the European market. As software has increasingly become
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
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