According to article 84 and annex III of Regulation (EU) 2017/745 on medical devices (MDR), manufacturers must draw up a Post-Market Surveillance (PMS) Plan.
As mentioned in previous articles, PMS takes an essential role in the MDR and is cross linked with risk management, clinical evaluation and other crucial processes. Manufacturers should thus make sure that the corresponding requirements are fulfilled.
As with other main topics, the European Commission falls short of expectations to publish useful guidance documents in a timely manner.
Recently, the ISO TR 20416 document was issued. It is intended to help manufacturers setting up a PMS system. Experts consider the report a useful supporting document to also comply with the corresponding MDR requirements.