1.Medical Device development and lifecycle management under the MDR and IVDR

The idea for a Medical Device often starts with an identified need. Initiating first steps involves an iterative process of research the results of which feed into shaping, modifying and finally deciding on either to abandon an idea or to pursue it. Research might encompass questions such as:

• How feasible is it to develop a successful product?
• What data are needed?                                                                    
• What will be the intended use of the invention? Who will use it?         
• Is it a Medical Device according to the definitions in the regulations?
• What risk class would the Medical Device be assigned to?
• What launch markets are suitable and what will be the regulatory strategy?
• What is the possible competitors’ landscape?
• Which investments are required?