MEDICAL DEVICE As of May 26, 2021, Regulation (EU) 2017/745 is fully applicable. The regulation amends the rules governing the medical device system and impacts manufacturers and economic operators (distributors, importers, and agents). Among the main changes introduced by the Regulation we find: - European database of medical devices (Eudamed)
- Definition and detailed obligations of all economic operators
- New figure of the person in charge of compliance with the legislation
- Supervision of notified bodies
- Clinical evaluation, post-market surveillance and PMCF (Post-Market Clinical Follow-up) plan
- Transparency and traceability of medical devices (UDI system)
- Devices that contain / consist of nanomaterials
Another of the recent innovations in the sector, not yet fully implemented, concerns the validation of software for the management of the quality system required by ISO 13485: 2016, paragraph 4.1.6.
This requirement is in addition to what had already been established in previous editions of the standard and which concerned the software applications directly involved both in the production process of electro-medical devices (7.5.6) and in monitoring and control activities (7.6).
The expectation of the Authorities is that the validation will take place in accordance with ISO / TR 80002-2: 2017.
This new request brings ISO 13485 closer to other standards such as 21 CFR Part 820, the standard recognized by the FDA for the marketing of medical devices on the US market.
Adeodata is at the forefront of supporting its customers with services designed specifically for the MD sector: - Gap Analysis between Directive 93/42 / EEC (MDD) and MDR / IVDR
- Support for MDSAP certification and Gap Analysis Report
- Support for the drafting of the Technical File
- Software validation
- First and second party audits
- Training of the personnel
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