For Combination Products, the intended use and mode of action is the deciding criterion whether the study is regulated by the MDD (93/42/EEC; 2007/47/EC)/AIMDD (90/385/EEC; 2007/47/EC) or the MPD (2001/83/EC; EU No 536/2014).
The MEDDEV Guidelines give more advice and information about requirements during the life cycle of a Medical Device to harmonize the processes within the EU. Section 2.1 of MEDDEV contains guidance on the scope, field of application, definition. In the MEDDEV 2. 1/3 rev 3, further information for borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative with significant examples are documented.
Although a unique process could be assumed due to existing EU Directives (MDD 93/42/EEC, AIMDD 90/385/EEC, MP 2001/83/EC), the implementation into national law in each EU Member State creates differences between the EU countries. Performing Clinical Studies, information on the national law of the participating Member States needs to be collected, and the most stringent applies for all.
Challenges resulting therefrom are for example: CA’s and EC’s responsibilities, notification contents, timelines, forms, routes may differ between the Member States; Language specific documents (e.g. ICF and Protocol Synopsis, etc.) are requested.
SAE reporting is always a very critical part of a Clinical Trial, and within the EU, differences between requirements by national Law between the EU Member States also appear. Andrea Offer, Medical Research Manager at NAMSA GmbH, Germany will speak about Medical Device Clinical Trials: SAE reporting requirements in Germany and Austria during this webinar covering:
- Legal background Austrian MPG and German MPG and German Ordinances,
- Reporting requirements (CA and EC),
- Timelines for Investigators and Sponsors
Andrea Offer is a Medical Research Manager at NAMSA, based in Germany. She worked as a registered nurse with specialities in orthopedics, gynecology, urology, vascular and visceral surgeries as well as endoscopy. She trained as a neurofeedback therapist and has a degree in technical journalism. As a Medical Research Manager, she has experience in project management of Pharmaceutical and Medical Device studies from planning, preparation, submission to ECs/IRBs and CAs, conduction and closure of studies, also included Medical Writing aspects as creation of observational plans, IBs, Monitoring Plans, ICFs and Assents, subject diaries and paper CRF. She has SAE-management experience including correspondence with (Pharmaco-) Vigilance and Safety-Review-boards, creation of SAE narratives / CIOMS reports and is aware of the similarities and differences in SAE and expedited reporting in Medical Device Studies and Pharmaceutical studies. Furthermore, she has developed some Data Management skills including secondary data-cleaning, verification of imported laboratory results and writing of verification reports, creation of overview-tables for laboratory-data import, and eCRF testing.