Meddev 2 12 1 rev 9 2025

Show details

4.9 out of 5

42 votes

The document MEDDEV 2.12-1 rev. 8 provides guidelines for a Medical Devices Vigilance System in the EU, aimed at improving patient safety by ensuring proper reporting and evaluation of incidents involving medical devices. It outlines the roles and responsibilities of manufacturers, national competent authorities, and users in reporting incidents and implementing corrective actions. The guidelines include definitions of key terms, criteria for incident reporting, and procedures for handling field safety corrective actions (FSCA). The document emphasizes the importance of collaboration among stakeholders to enhance vigilance practices across member states.

Here's how it works

01. Edit your meddev guidance online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send meddev via email, link, or fax. You can also download it, export it or print it out.

The easiest way to modify Meddev 2 12 1 rev 9 in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Working on paperwork with our comprehensive and user-friendly PDF editor is easy. Follow the instructions below to complete Meddev 2 12 1 rev 9 online quickly and easily:

Log in to your account. Sign up with your credentials or register a free account to try the product before upgrading the subscription.
Upload a document. Drag and drop the file from your device or add it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit Meddev 2 12 1 rev 9. Effortlessly add and underline text, insert pictures, checkmarks, and signs, drop new fillable areas, and rearrange or delete pages from your document.
Get the Meddev 2 12 1 rev 9 accomplished. Download your updated document, export it to the cloud, print it from the editor, or share it with other participants through a Shareable link or as an email attachment.

Benefit from DocHub, the most straightforward editor to promptly manage your paperwork online!

See more meddev 2 12 1 rev 9 versions

We've got more versions of the meddev 2 12 1 rev 9 form. Select the right meddev 2 12 1 rev 9 version from the list and start editing it straight away!

Versions	Form popularity	Fillable & printable
2013	4.9 Satisfied (42 Votes)

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is the current revision of MEDDEV 2.7 1?

Revision 4 of Clinical Evaluation guidance document MEDDEV 2.7. 1 was released by the European Commission on 1 July 2016. A copy of the latest revision can be downloaded from our website.

Are MEDDEV documents still valid?

With the replacement of the EU directives MDD, AIMDD, and IVDD by the EU regulations MDR and IVDR, the MEDDEV documents are largely obsolete. One exception is, for example, the MEDDEV 2.7/1 rev 4 guideline. Manufacturers and notified bodies should, therefore, always check whether there is a suitable MDCG guideline.

What is an adverse event in MEDDEV?

Adverse event: any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.

What is the difference between clinical development plan and clinical evaluation plan?

The clinical development plan defines how you will collect sufficient clinical data for later clinical evaluation. It is the first step of the overall clinical evaluation plan. The Clinical Development Plan should indicate potential acceptance criteria.

What is the main difference between MDR and MDD?

How Is MDR Different Than MDD? Because a regulation is a more binding standard, and is not subject to individual interpretation by the member states, in theory, the MDR would become a more powerful tool for assuring conformity for medical devices across the European marketplace.

meddev 2 12 1

meddev 2.12-1 latest version MEDDEV 2.12/1 rev 8 MEDDEV 2.12/2 rev 2 Is MEDDEV 2.12-1 still valid MEDDEV 2.7/1 rev 4 MEDDEV 2.4/1 rev 9 meddev 2.7/1 rev 5 Additional guidance regarding the vigilance System as outlined in MEDDEV 2.12-1 rev 8

What is the difference between MEDDEV and Mdcg?

MEDDEV guidance documents, like 2.7/1 Rev. 4, are aligned with the old Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). MDCG guidance documents, on the other hand, are aligned with the new EU Medical Device Regulations (MDR).

What is the role of the Mdcg?

The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation to market surveillance, passing by international matters, new technologies and clinical investigation.