Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes

PDA Technical Report No. 73-2:Application of Medical Device Regulations, Annex I Requirements (GSPRs) for Staked Needle Syringes represents the current state of knowledge as to the application of European Union Regulation (EU) 2017/745 on medical devices (MDR). As this is a new regulatory requirement, expectations of the Notified Body (NB) and competent authorities may diverge as the process evolves.As an addendum to PDA Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications, thistechnicalreport provides recommendations on preparing the required documentation of thedevicepartofthePFS to facilitate obtaining an NB opinion. It systematically recommends the amount and depth of information needed for each relevant GSPR to support pharmaceutical companies in assembling the submission file to the NBs and provides information on documents that provide guidance on completing the NB submission file. The device part, including its corresponding componentsandmaterials, are in scope as they will be evaluated by the NBs, but the medicinal product (drug) is not.