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MEDLEY 2 12-1 rev. 7 Vigilance EUROPEAN COMMISSION DG Health and Consumers (SANCHO) Directorate B-Consumer Affairs Unit B2- Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDLEY

How to fill out meddev 2 12-1 rev

How to fill out meddev 2 12-1 rev?

1. Begin by collecting all the necessary information and documents required for filling out meddev 2 12-1 rev. This may include medical device specifications, risk management plans, clinical evaluation reports, and any other relevant data.
2. Familiarize yourself with the structure and sections of the meddev 2 12-1 rev form. Understand the purpose of each section to ensure accurate and complete information is provided.
3. Start by filling out the general information section, which includes details such as the manufacturer's name, address, and contact information. Ensure that all these details are up to date and accurate.
4. Move on to the identification section where you will provide specific information about the medical device, such as its intended purpose, classification, and any previous versions or variants.
5. Proceed to the assessment section, where you will evaluate the conformity of the medical device with relevant regulations and standards. Provide detailed information on the risk analysis, clinical data, and performance evaluation conducted for the device.
6. In the post-market surveillance section, outline the measures taken to monitor the device's performance after it has been placed on the market. Include any adverse events, complaints, or other relevant information.
7. Next, complete the summary of safety and performance section, summarizing the key safety and performance characteristics of the medical device. Include any non-conformities or corrective actions taken.
8. Lastly, review the filled-out meddev 2 12-1 rev form to ensure all fields are accurately completed and no information is missing. Double-check for any inconsistencies or errors before submitting the form.

Who needs meddev 2 12-1 rev?

1. Medical device manufacturers who plan to place their products on the market within the European Union may need to fill out meddev 2 12-1 rev. This is especially relevant for devices that fall under the scope of the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR).
2. Regulatory authorities and notified bodies also utilize meddev 2 12-1 rev to assess the conformity and safety of medical devices. These bodies rely on the information provided in the form to make informed decisions regarding device approval and market access.
3. Healthcare professionals, distributors, and other stakeholders in the medical device industry may also benefit from understanding meddev 2 12-1 rev. Being familiar with the form can help ensure compliance with regulations and contribute to the overall safety and performance of medical devices in the market.

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What is meddev 2 12-1 rev?

MEDDEV 2.12-1 rev is a document that provides guidance on the clinical evaluation of medical devices.

Who is required to file meddev 2 12-1 rev?

Manufacturers of medical devices are required to file MEDDEV 2.12-1 rev.

How to fill out meddev 2 12-1 rev?

MEDDEV 2.12-1 rev should be filled out by following the guidance provided in the document and including all relevant information.

What is the purpose of meddev 2 12-1 rev?

The purpose of MEDDEV 2.12-1 rev is to ensure the clinical evaluation of medical devices is conducted in a systematic and thorough manner.

What information must be reported on meddev 2 12-1 rev?

Information that must be reported on MEDDEV 2.12-1 rev includes details of the medical device, its intended use, clinical data, and evaluation methods.

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