Medical Device News: February 2022 Regulatory Update

Medical Device made Easy Podcast · Feb 1, 2022

The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements.

Agenda:

IVDR news on transition, Expert Panel and Finland reminder

Clinical Trial Regulation in EU and UK

Training EU MDR 2017/745

EUDAMED Certificate module

EU Reinforced role for EMA on medical device and medicinal product shortage

Harmonized Standards

Annex XVI Draft

Switzerland Good Reprocessing Practices

Re-registration within MHRA

Bahrain medical device that doesn’t need registration

Newsltetter: FDA Medsun and Japan PMDA

MDCG guideline…