Regulatory Focus

1 month ago | raps.org

The European Commission is asking for stakeholder input on a plan to allow electronic medical device instructions for use (eIFU) be provided to healthcare providers for all devices, not just high-risk products. The consultation was released on 21 February and stakeholders have a month to provide feedback. @

1 month ago | raps.org

The staffing cuts at the US Food and Drug Administration (FDA) have created a climate of uncertainty surrounding clinical trials. As a result, many companies are considering the possibility of developing drugs in other countries. This situation is perceived by some as a @gift to China,@ which has been intensifying its efforts in the pharmaceutical space, according to Jeremy Levin, CEO of Ovid Therapeutics. @

Jan 20, 2025 | raps.org

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to help medtech manufacturers comply with its updated postmarket surveillance (PMS) regulation, which goes into effect this summer. The guidance was published alongside other guidances that sponsors should refer to ensure their specific product complies with the upcoming regulation.

Jan 16, 2025 | raps.org

Legislation passed late last year introduces clearer, more stringent PMS requirements proportionate to each device@s risks. The new law improves regulatory oversight, increases the scope of devices subject to PMS requirements, and requires manufacturers to have a postmarket surveillance plan and system. It comes into force on 16 June. @

Jan 7, 2025 | raps.org

The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation program. @