EBE-EFPIA Position Paper: Approach to Substantial Design Change of the Integral Medical Device Constituent Part Under Article 117: A Risk Based Approach
Since the issuance of the EMA/CMDh “Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746), Rev.1”, 21st October 2019, industry has open-questions with regards to what constitutes a ‘substantial design change’ and is requesting EMA to provide a regulatory framework upon which basis,