The European Union's Regulation (EU) 2017/745 regulates the clinical investigation and sale of medical devices for human use. It mandates several requirements for medical device manufacturers aiming to sell and distribute their products across European member states. Among these requirements is the necessity to identify and test the safe disposal method of the device itself, its accessories and consumables and any related waste substances. The medical device's Instructions for Use (IFU) must also include the validated disposal procedure. Traditionally, manufacturers have relied upon conducting the actual disposal validation exercises to address this regulatory requirement.

However, this conventional approach presents several challenges, including identifying and outsourcing a suitable vendor, not utilizing existing resources, needing experts to govern and report the findings, higher execution costs and larger turnaround times. Nonetheless, these shortcomings can be mitigated by adopting an alternate strategy for validating the disposal method.

Our whitepaper proposes employing a systematic literature search to justify the regulatory requirement on safe disposal for pre-validated disposal techniques like the autoclave method. Download it now.