In the field of medical devices (MDs) and in vitro medical diagnostics (IVDs), Di Renzo Regulatory Affairs provides consulting services to Italian and foreign companies that manufacturing, marketing, exporting and importing these products.
It has a unit composed of highly qualified technical personnel with long experience in this sector.
This unit is able to provide normative and procedural support to companies interested in European and non-European markets.
Our team can assist you in the following activities (custom-made assistance services are discussed with Customers based on their needs):
- Consultancy on the national, European and extra-European legislation (for specific countries)
- Strategy consultancy and feasibility check on the company project, with indication of: product regulatory frame, classification, requirements to be complied with, costs
- Due diligence and control of the compliance of the product technical documentation with the requirements of the applicable national and European regulations
- Gap analysis on the documentation available to the Customer and on the company status in respect of Regulations 745/2017 and 746/2017
CE marking stage
- Contacts with Notified Bodies and consultancy to obtain the CE marking
- Contacts with qualified laboratories to carry out tests on devices
- Drafting/review/update of product technical dossiers in order to obtain/maintain/renew the CE certificates
- Drafting/review/update of bibliographic clinical assessments
- Drafting/review/update of risk analyses documentation
- Control/review of labels and use instructions/handbooks
- Assistance with the Notified Body until the CE marking is obtained and for the maintenance of the certification
- Preparation of the documentation for authorisation application of clinical trials to Ethics Committees and Competent Authorities
Marketing and post-marketing stage
- Registration of manufacturers and MD and IVD notification to the Ministry of Health and to the Competent Authorities of other EU Member States.
- Post-marketing surveillance (PMS) according to the requirements of the current Directives and of the new European Regulation
- Device-vigilance, with the taking on of the role of vigilance responsible person
- Consultancy for companies acting as local representatives (i.e. contacts with EU Competent Authorities, product notification, incident reporting, etc.)
- Consultancy on the regulatory procedures for import/export activities and request of free sale certificates (CLV)
- Drafting/review of advertising material and authorisation application to the Authorities
- Creation/update/maintenance of the company quality management system according to ISO 13485:2016 and in compliance with the provisions of the current European directives and of Regulations 745/2017 and 746/2017.
- Taking on the role of QA
- Contacts with Certifying Bodies for the ISO 13485 certification
- Assistance until the ISO certificate is obtained and for the maintenance of the certification
- Assistance on activities following the implementation of the required management systems
- Audits at companies and suppliers and assistance during audits
- Training courses