Clinical Evaluation Procedure and Webinar Bundle

Purchase of this bundle will enable you to quickly update your clinical evaluation procedure and train employees to MEDDEV 2.7/1 rev 4.

Is this Clinical Evaluation Procedure updated to the EU MDR (i.e., Regulation 2017/745)?

As stated in the video above, we are in the process of updating the procedure to include references to the newest guidance documents from the MDCG:

• MDCG 2020-13 – Clinical evaluation assessment report template
• MDCG 2020-6 – Guidance on sufficient clinical evidence for legacy devices
• MDCG 2020-5 – Guidance on clinical evaluation – Equivalence

We are adding more detailed references to Article 61 and Annex XIV, Part A. Despite the changes, the process still follows MEDDEV 2.7/1 rev 4. Edits will be completed sometime in January 2024. As always, procedure updates are free for anyone who purchased a prior version.

Clinical Evaluation Procedure and Webinar Bundle available for $299.00:

SYS-041 - Clinical Evaluation Procedure and Webinar Bundle

This procedure and webinar bundle includes requirements for European MDR (Regulation 2017/745) and MDCG guidance documents.

Price: $299.00

 Typically, webinars are sold on our website for $129, and procedures are sold for $299. This bundle is sold for $299. As always, you receive a copy of the native slide deck and a link for downloading the recording.

Important Note: If you have already purchased the previous version of this procedure, you will receive the procedure update and webinar bundle at no charge.

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.

1. Clinical Evaluation Procedure 

Purpose – The purpose of this procedure is to define the process for performing a clinical evaluation following MEDDEV 2.7/1 rev 4.

Scope – This is the primary document meeting the applicable regulatory requirements for Clinical Evaluations as defined in the Quality System Manual (POL-001). Generally, this requires including the following elements in your Technical File (SYS-025) following Article 61 and Annex XIV Part A of the EU MDR:

• Clinical Evaluation Report
• Updates to the Clinical Evaluation Report
• Clinical Evaluation Plan

Consultants providing services approved by the company may rely on their procedure(s) instead of this procedure. Qualification and evaluation of a consultant is controlled by the Supplier Quality Management Procedure (SYS-011)…

2. Literature Search Protocol (TMP-004)

Blog on Clinical Evaluations

In June of 2017, the fourth revision of the guidance document for clinical evaluations was released. An overview of the updated guidance document can be found in the Medical Device Academy Blog by clicking here.

What will you receive when you purchase this bundle?

Anyone who purchases the clinical evaluation procedure and webinar bundle will receive an automated email via AWeber that includes an invitation to the live webinar and a link to the Dropbox folder with the following files:

• Updated version of the Clinical Evaluation Procedure (SYS-041)
• The associated literature search protocol template
• Native Slide Deck for the Webinar
• Recording of the Webinar

You will also receive access to any future updates to the procedure.

When is the webinar for the Clinical Evaluation Procedure?