Determining whether a product is a medical device is a complex and time-consuming task. In fact, Article 2 of the EU’s Medical Device Regulation (MDR) defines a medical device with six different medical purposes – and over 70 related terms.

Here’s the thing. Suppliers of medical device components are not directly regulated by the Medical Device Regulation (MDR). But keep reading. Compliance for legal manufacturers requires the receipt of sufficient information from suppliers. That puts legal manufacturers in complete control of their own supply chain. In effect, this makes them the sole custodians of medical device safety.

A complaint can come from any source – a patient, a doctor, or someone else involved with a medical device – anyone unhappy with the product or service. Complaints also arise from internal review and/or testing, where an issue is discovered and reported through designated channels. With Software as a Medical Device (SaMD) complaints can even originate from error logs.