Complying with Article 117
Does my medicinal product need to comply with MDR Article 117?
The new Medical Device Regulation 2017/745 brings drug delivery devices into its remit in Article 117. If the primary product is the device and the pharmaceutical drug is ancillary, then it is a Class III medical device. If the drug and the device are integral (and single use), it is regulated as a medicinal product Directive MDP 2001/83/ec. This applies to devices that are intended to be used with the associated drug supplied with it and only the drug with which it forms an integrated product for single use.
Pharmaceutical, biotech and biosimilar companies whose products come under the regulation must generate evidence of compliance or secure an opinion from a Notified Body stating the general safety and performance requirements of MDR Annex1 (GSPR) are met.
MET can provide the risk analysis and testing services to generate the required evidence for compliance. Since Notified Bodies are in short supply and their work load is high, MET can provide this service for you and simplify your interaction with the regulators.