Vigilance Reporting Under the MDR: Insider’s Guide

By |2023-01-16T20:21:46+00:00January 17th, 2023|

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations.   The regulations are clear that medical device manufacturers and authorized representatives (AR) must take action to notify competent authorities [...]

The UK MDR and The EU MDR: What Are The Differences?

By |2023-01-10T17:03:58+00:00January 10th, 2023|

UK MDR is the primary standard that mandates requirements for anyone selling medical products in the UK, as it is a vast market that often goes unexplored. After the UK left European Union, there has been some confusion regarding the regulations for medical devices in the UK, mostly whether one's device is eligible to [...]

Top Regulatory Updates in 2022: New Documents, Regulatory Scandals, and Useful Information

By |2023-01-03T18:49:13+00:00January 3rd, 2023|

2022 was quite the year. While the pandemic slowly fizzled, medical device companies and medical writers enjoyed new guidelines and regulations, first-row seats to the biggest recall in FDA history, and a bunch of odd decisions made by regulatory agencies.   Today we are looking at the biggest stories and most important regulatory updates of [...]

How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR

By |2022-12-15T13:13:02+00:00December 14th, 2022|

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product.   Literature reviews are essential for manufacturers to ensure that the IVDR has been constructed according to current regulatory requirements and that it is based on [...]

What to Look for in a Clinical Evaluation Report Writer

By |2023-01-09T20:07:11+00:00December 13th, 2022|

Writing a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745) can be challenging. Ever stricter requirements for clinical evidence, data appraisal, and literature search processes have caused many medical writers to despair. The updates to the regulation are also causing problems for medical device manufacturers, who can no longer find [...]

Vigilance: IVDR – A Review of Vigilance Regulations for In Vitro Diagnostic Devices

By |2022-12-15T13:11:18+00:00December 6th, 2022|

The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; they are now clearly distinguished and treated as separate entities.   Reporting requirements in the previous Directive were not considered [...]

IVDR FAQ and Best Practices for The Vigilance of In Vitro Diagnostic Medical Devices

By |2022-12-15T13:11:18+00:00November 15th, 2022|

The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, and other users by reducing the probability of reoccurring serious incidents related to in vitro diagnostic medical devices. For that to happen, EU member states and their national competent authorities must be aware of any serious incidents and actions are [...]

Market Surveillance of Medical Devices Under the EU MDR

By |2022-12-15T13:11:19+00:00November 8th, 2022|

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures in place to verify and guarantee the regulatory compliance of products and to establish processes and appropriate measures for diminishing [...]

The Post-Market Surveillance Document: Which Ones Do you Need?

By |2022-12-15T13:11:19+00:00November 1st, 2022|

It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, including devices that have been incorporated or are intended to be incorporated into a medical device system (i.e., active implantable [...]

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