The Road Map will evaluate the regulatory development requirements for a Medical Device (MD) and In Vitro Diagnostics (IVD) to obtain the CE mark under the new MD and IVD Regulations.
The Road Map includes analysis and advice on potential regulatory, non-clinical and clinical investigations as well as on MDR specific activities to support the certification of the MD. The Road Map will also include fast pathways to certification, including the pros, cons and risks of the alternatives and a description of the timings of the regulatory applications.
How can DDR help?
- DDR will provide regulatory assessment and recommendations regarding the MD and IVD classification.
- DDR will propose a development strategy to comply with the General Safety and Performance Requirements (GSPRs), including an analysis of the available data on the device and the potential need for a clinical investigation.
- DDR will delineate the post-marketing activities required for a device under the new Regulations.
- DDR will check the opportunities for interactions with key Notified Bodies (NB) and the Medical Device Experts Groups (MDCG), as appropriate.