The Medical Devices sector with the entry into force of the new legislation European Union-Medical Device Regulation No. 745/2017 will be affected by significant changes.
The new legislation, among the major impacts, will entail a strengthening of the designation criteria, of the surveillance processes and the role of Notified Bodies, of the clinical evaluation criteria and clinical investigations.
Post-marketing surveillance will become a requirement, meaning that companies must have in place systems to support their surveillance: a quality management system, a risk management system, a vigilance system for reporting incidents to competent authorities and prompt corrective actions.
- understand the requirements and the full implications of the MDR
- perform a gap analysis of current issues, reviewing and assessing what companies will have to do to meet the requirements
- create a detailed road map to help you meet the requirements, including assessment of feasibility, strategy, timelines and costs
- establish a system of maintenance support to ensure full compliance
- revise the available documentation according to the current regulations to apply for authorisation, preparation of the application, submission and follow-up
- prepare and/or review labelling and promotional material
- translate texts and labels from / to the following languages: Italian, English, Spanish, French, German
- elaborate labels mock-ups
- establish contacts with Notified Body and/or Regulatory Authorities
- perform post-marketing surveillance
- Clinical Program Development
- Clinical Trial Application
- Health Authority/ agency Interaction
- Clinical Operations
- Pediatric Investigation Plan (PIP)
- Scientific Writing
- Statistical Services
- Global Procedure Management