On 12 March 2025, Decision No. Δ3(α)4822 was issued, which amends and codifies the Ministerial Decision ΔY8δ/ Γ.Π.οικ.1348/2004, published in Government Gazette 32/B/16-1-2004 and specifies the principles and guidelines for good practice in the distribution of medical devices.
This new decision, published in Government Gazette 1197/B/12-3-2025, adapts the provisions to the requirements of the new European Union Regulations on medical devices, specifically Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
Key changes:
- The verification and compliance with the principles and guidelines of the system is the responsibility of the Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices.
- For orders and returns of overdue/expired medical devices, the provisions of the Guidelines on Good Distribution Practice for Pharmaceutical Products for Human Use of the 5th of November 2013 (2013/C 343/01), as incorporated into national legislation, shall apply accordingly. All distributors of MD are obliged to withdraw from their customers medical devices that are recalled or that have expired or are due to expire within six months and to issue a mandatory credit invoice, applying by analogy the provisions of Article 19 of Law No. 3204/2003 (Α’ 296).
For detailed information, read the relevant Government Gazette.