Resource Library

DDC Discussion Group Resources
Annex I GSPRs Medical Device Regulation 2017_745.pdf (475.9 KB)
EMA draft-guideline-quality-requirements-drug-device-combinations_en.pdf (303.0 KB)
EMA_CMDh Q&A on Implementation of the MDR & IVDR Rev.1 Oct 2019.pdf (156.3 KB)
Medical Device Regulation 2017_745.pdf (1.4 MB)
Team-NB_Position-Paper_on-Documentation-Requirements-Article117-V1.pdf (348.2 KB)

General Articles
Articles on combination products.doc (26.5 KB)

Meeting Minutes
MTspin-Minutes_Actions_09Dec14.doc (139.5 KB)

Regulatory Rapportuer Articles
Regulatory Rapporteur device articles.docx (57.9 KB)

TOPRA Polices
Social media policy.pdf (20.3 KB)
Volunteering for TOPRA.pdf (93.0 KB)

29 June 2018 - Draft Manufacturer Incident Report (MIR) webinar.pdf (2.4 MB)
29 June 2018 - MedTech webinar final presentation.pdf (1.4 MB)
CMC MedTec Combo Products Webinar final with QA.pdf (3.4 MB)
Final - TOPRA Webinar Combination Products M Jorvid-J Jamieson 27Jan2017.pdf (4.0 MB)
MedTech SPIN Webinar Device Regulatory Professionalism- 19 Sept 17.pdf (1.2 MB)
TOPRA Medtech SPIN Webinar - Overview of the PMS in EU final.pdf (1.2 MB)
Transitioning to MDR’s clinical evidence requirements webinar presentation 9 April 2018.pdf (459.0 KB)