Regulatory

With the entry into force of the new Regulation on Medical Devices MDR 745/2017 , which will have full application starting in May 2021, the entire sector is going through a moment of profound change that requires the detailed understanding of the new obligations to be borne by the manufacturing companies and by the different actors of the system, as well as of the many innovations introduced by the Regulation in terms of training, clinical investigations, and much more.

Thanks to the skills of its collaborators in the field of electromedical equipment and medical devices in general, and thanks to an important network of collaborations, MedTech Projects provides 360° consultancy support on regulatory issues.

Detailed GAP analysis with evaluation of the current company situation with respect to the obligations required by RDM 745/2017:

  • Device related activities (qualification and new classification, general safety and performance requirements, clinical evaluation, …)
  • Documentation (technical file, labels and usage information, document storage, CE certificates, declarations of conformity, …)
  • Quality (quality system, responsible person, risk management, …)
  • Post-marketing control (surveillance, clinical follow-up plan, recording and reporting of incidents, …)
  • Relations with third parties (suppliers, distributors, OBL manufacturers, OEM manufacturers, …)

Implementation of the company quality system:

  • Implementation of the company quality management system in accordance with the EN ISO 13485: 2016 and EN ISO 9001: 2015 standards (drafting of the quality manual, definition of company procedures, etc.)
  • Identification of the Certification Body / Notified Body for the integrated certification EN ISO 13485: 2016 and EN ISO 9001: 2015 and support in the company’s relations with the EC / ON during the certification process
  • Support for carrying out internal inspection visits (1st and 2nd part) and management review

Regulatory support for the certification of medical devices (drafting of the technical file, risk analysis, relations with the Notified Body, etc.)

Registration of medical devices in the “Banca Dati” and “Repertorio Dispositivi Medici” at the italian Ministry of Health

Regulatory support for import / export of medical devices

Support for laboratory tests (electrical safety, electromagnetic compatibility, sterility and useful life, biocompatibility, etc.)

Analysis of the line of medical devices manufactured and / or marketed by the company with segmentation of the different cases in which:

  • The products offered qualify or not as a Medical Device (an opinion will be provided regarding “borderline” products)
  • The company operates as an OBL (Own Brand Labeller) manufacturer, marketing devices from other manufacturers that already provide the CE marking of the same devices
  • The company operates as a manufacturer by remarking the devices on behalf of third parties that operate as OBL
  • The company operates as a manufacturer by purchasing devices produced by third parties but not yet CE marked
  • The company operates as a manufacturer (OBL or not) by marketing the devices through distribution companies
  • Etc.

OBL contracts: collection and analysis of the contractual documentation currently in place between the company and its suppliers “upstream” (real OEM manufacturers) and / or “downstream” customers (OBL virtual manufacturers)

Distribution contracts: collection and analysis of the contractual documentation currently in place between the company and its distributors or between the company and its suppliers (for which the company operates as a distributor)

Person responsible for regulatory compliance (Art. 15 MDR): support for the internal company person and possible assumption of the role in outsourcing

Provision of training courses for regulatory matters

 

Note: We provide dedicated legal support through a stable collaboration with a law firm specializing in medical device issues

 

Contact us for more information.