MEDICAL DEVICES AND DIAGNOSTICS

In the European Union (EU) medical devices must undergo a conformity assessment to demonstrate they meet legal requirements to ensure their safety and performance. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the manufacturers of certain categories of medical devices.

PHA FARMED is committed to medical device manufacturer to manage regulatory affairs – QMS – performance study efficiently, on budget and respecting time-lines.

• Preparation of regulatory strategy in compliance with MDR and IVDR
• Classification among different categories
• Performance studies
• Review of technical documentation from the manufacturer
• Preparation of technical file
• Registration EUDAMED
• Obtaining UDI
• Engagement of notified body, opinions from specific expert panels, scientific opinions
• Placeing a CE (Conformité Européenne) mark
• QMS – conformity assessment usually involves an audit of the manufacturer’s QMS compliance with ISO 13485:2016 – Lead Auditor of the manufacturer, ISO 20916:2019 – IVDR, ISO 9001:2015 – QMS
• Importer – Qualified Person (QP) – Responsible Person (RP)
• Authorised representative/ Sponsor
• Vigilance (V) – post-market surveillance system and plan