Post Market Surveillance

  We've explored post-market surveillance (PMS) for medical device manufacturers many times, for example, in our articles on post-market surveillance under the MDR, MDR post-market surveillance compared to the IVDR, and the relationships between [...]

The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system [...]

A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices.   The [...]

Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure [...]

This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff in the various parts of Post Market Surveillance (PMS) for MDR compliance! [...]

  No matter how hard you try as medical device manufacturer to make sure your device is safe and efficient, adverse events can still happen. Even the most vigorously tested medical devices have adverse [...]

There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously [...]

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]

Breaking Down EU MDR Implementation for Class 1 Medical Devices   Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I [...]

All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and IVDR. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary.   [...]

Guide - MDCG endorsed documents and other guidance documents. The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article [...]

Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance.  This section of MDR deals with how your firm [...]