ACTIVITES GARDEN PARTY

NOTIFICATION DES DM - GRECE

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Welcome to PREVOR, a company specializing in chemical decontamination solutions. You are a member of the Quality System Group. Your role is to ensure regulatory compliance and product quality before products are released to the market. MISSION: Help the Quality System Group achieve its two objectives :

• Level 1– Quality Control:
  • Verify product compliance prior to market release.
• Level 2 – Regulatory Affairs:
  • Ensure that products are registered in the relevant country.

OBJECTIVE: Answer the questions correctly to demonstrate your knowledge and ensure the product’s safe release to the market.

Bienvenue dans PREVOR, spécialisée dans les solutions de décontamination chimique. Tu es membre du Groupe Qualité Systéme.Ta mission est de garantir la conformité réglementaire et la qualité des produits avant leur mise sur le marché. MISSION: Aide le service Qualité à réussir ses deux objectifs :

• Niveau 1– Contrôle Qualité:
  • Vérifier la conformité des produits avant commercialisation.
• Niveau 2 – Réglementaire:
  • Assurer la notification des produits dans le pays concerné.

OBJECTIF: Répondre correctement aux questions pour valider tes connaissances et sécuriser la mise sur le marché.

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CONTEXT:

You will be working in PREVOR’s Quality Systems department. Your company has been selling these medical devices (DIPHO, HEXA) directly in Greece for years. Greek national law requires that medical devices already sold on the Greek market be notified. Your mission is to complete the notification process for the targeted medical devices to ensure compliance with marketing regulations and secure PREVOR’s market position by adhering to Greek national law.

cOMPRIS/ UNderstood

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CONTEXT:

You will be working in PREVOR’s Quality Systems department. Your company has been selling these medical devices (DIPHO, HEXA) directly in Greece for years. Greek national law requires that medical devices already sold on the Greek market be notified. Your mission is to complete the notification process for the targeted medical devices to ensure compliance with marketing regulations and secure PREVOR’s market position by adhering to Greek national law.

cOMPRIS/ UNderstood

cOMPRIS/ UNderstood

MEDICAL DEVICES NOTIFICATION

For all medical devices placed on the Greek market, Manufacturers or their EC-Authorized Representatives are required to submit to the National Organization for Medicines, all data allowing for the identification of such devices together with the label and the instructions for use when such devices are placed on the market and are put into service in Greece. The required documents are the following: 1. Declaration of Conformity by the Manufacturer 2. CE Certificate / certificate of registration to a Competent Authority (for low risk devices) 3. Instructions for Use 4. Labels The link for the Greek database for Medical Devices is: http://services.eof.gr/gremdis/ The e-mail address where the relevant information can be sent is: medicaldevices@eof.gr The company which distributes medical devices must possess a Certificate for the Distribution of Medical Devices by a Notified Body in accordance with the provisions of Ministry Decision 1348/16.01.2004 (Principles and Good Distribution Practice Guidelines). For the distribution of Medical Devices the labeling and instructions for use should be complete and accurate in the Greek language, for the final user.

cOMPRIS/ UNderstood

cOMPRIS/ UNderstood

MEDICAL DEVICES NOTIFICATION

For all medical devices placed on the Greek market, Manufacturers or their EC-Authorized Representatives are required to submit to the National Organization for Medicines, all data allowing for the identification of such devices together with the label and the instructions for use when such devices are placed on the market and are put into service in Greece. The required documents are the following: 1. Declaration of Conformity by the Manufacturer 2. CE Certificate / certificate of registration to a Competent Authority (for low risk devices) 3. Instructions for Use 4. Labels The link for the Greek database for Medical Devices is: http://services.eof.gr/gremdis/ The e-mail address where the relevant information can be sent is: medicaldevices@eof.gr The company which distributes medical devices must possess a Certificate for the Distribution of Medical Devices by a Notified Body in accordance with the provisions of Ministry Decision 1348/16.01.2004 (Principles and Good Distribution Practice Guidelines). For the distribution of Medical Devices the labeling and instructions for use should be complete and accurate in the Greek language, for the final user.

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Je suis un paragraphe prêt à accueillir votre créativité, vos histoires et vos anecdotes.

Je suis un paragraphe prêt à accueillir votre créativité, vos histoires et vos anecdotes.

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