Medical Devices — Compliance & Good Distribution Practice

ROUSSAKIS SUPPLIES IKE supplies medical devices, such as our car first aid kit with contents according to DIN 13164:2022 (manufacturer’s declaration). On this page you will find the certificate under which we operate as a distributor of medical devices, what exactly it covers, and how to contact us about any problem.

Good Distribution Practice Certificate under Ministerial Decision Δ3(α)4822/2025

Greek Ministerial Decision Δ3(α)4822/2025 (Government Gazette B’ 1197/12.03.2025) applies to businesses that import, distribute, move within the EU or export medical devices, except manufacturers distributing their own products. It sets out Good Distribution Practice principles so that devices are not altered and their quality is not degraded during distribution. Compliance is verified by Notified Bodies, which issue a certificate valid for three years, subject to annual surveillance audits, and notify it to the Greek National Organisation for Medicines (EOF). The EOF checks that medical devices are distributed only by businesses holding a valid certificate (private pharmacies are exempt from the certificate requirement).

Our company holds the following certificate:

• Certificate no.: 32101 C10 26 10 01
• Issued by: HTCert (Health Technology Certification), Nicosia, Cyprus, a Notified Body under Regulation (EU) 2017/745, identification number 2803 (this number identifies the certification body; it is not the CE marking of the products we supply)
• Scope (translated from Greek): “Applies the Principles and Guidelines for Good Distribution Practice of Medical Devices”
• Site: G. Papandreou & Fanarioton, 193 00 Aspropyrgos, Greece
• Validity: 27/10/2026 to 26/10/2029, subject to successful annual surveillance audits

View the certificate (PDF, in Greek)

What the certificate covers. The certificate covers how our company receives, stores, distributes and records medical devices. It is not a certification of the products themselves. Under Regulation (EU) 2017/745, each device’s manufacturer is responsible for its conformity (CE marking, declaration of conformity).

What We Do under Good Distribution Practice

In line with Article 3 of Ministerial Decision Δ3(α)4822/2025:

• We store and transport medical devices under the conditions set by the manufacturer.
• We keep written procedures for receiving, storing and distributing them, with a designated person responsible for applying them.
• For every purchase and sale we record the date, the product, the lot or serial number where required, and the supplier or recipient, so that we can identify which customers received a product. Records are kept for at least the lifetime of the product and in any case for no less than five years.
• We keep a register of complaints, non-conforming products, recalls and withdrawals.
• We keep products that cannot be supplied, such as expired, unsuitable or recalled items, in a separate, clearly marked area.

The Notified Body checks this every year through a surveillance audit.

Registration with the EOF

Our company is registered as a distributor in the medical device register of the Greek National Organisation for Medicines (EOF). In the same register we have notified the car first aid kit we supply (EOF code 2820015518448). Registrations and notifications in the register record information; they are not an EOF approval of the quality, safety or performance of the products.

Complaints, Incidents and Recalls

If you find a problem with a medical device you bought from us, for example damaged packaging, missing contents, a labelling error or an incident during use, please contact us:

• Email: info@roussakis.com.gr
• Phone: +30 210 5582077
• Address: G. Papandreou & Fanarioton, 193 00 Aspropyrgos, Greece

If possible, tell us the product name, the REF and LOT codes from the label and your order number. We record every report in our complaints register and, where required, inform the manufacturer and the competent authorities. If a product is recalled, our distribution records allow us to identify and inform the customers who received it.

Last updated: November 2026