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, changes should be considered and managed using a risk-based approach within the current variations guidance and process.
Given medicinal products with an integral medical device (DDCs) are governed as medicinal products under Directive 2001/83/EC as amended, the EMA/NCAs have overall accountability for these products. As such, industry is looking for guidance on a definition of ‘substantial change’ in respect to managing changes given the current EU variations classification guideline (EC 1234/2008, 24 November 2008) does not adequately address changes to the device constituent of an integral DDC.
Whilst the longer-term objective of the EMA should be to update the variation regulation and associated variation categorisation guideline to better accommodate single integral DDCs, the short term target to meet the 26 May 2020 MDR implementation, is to provide industry with a framework that supports the determination of a ‘substantial change’ that ensures changes to the device constituent of single-integral DDCs are approached. The aim of this proposal is to achieve categorisation of device design changes in a consistent manner such that the summary of information within the market authorisation is suitably maintained to ensure that product quality and ultimately patient safety are not compromised.
Read the full Position Paper here.