The new regulation on medical devices EU 2017/745 has provided a more detailed definition of the Drug Device Combination Products (DDCs) in the EU, covering also quality and regulatory requirements.
For integrated DDCs intended to administer a medicinal product, article 117 also amends the Directive 2001/83/EC, requiring the applicant to include the results of the assessment of the conformity of the device constituent with the relevant General Safety and Performance Requirements (GSPR) in the marketing authorization dossier.
These changes have increased the discussion among the container closure system manufacturers, as it seems not fully clear how a sub-assembled device can be demonstrated to fulfil regulatory expectations.
This PDA Webinar therefore aims to address relevant industry stakeholders interested in collaborating on a Technical Report document to support component manufacturers in providing the applicant with the appropriate information on device conformity with the relevant GSPR.
The discussion will involve industry representatives as well as provide Notified Body Opinion.
We look forward to constructive collaboration and problem solving, and warmly invite you to join us!