Self-Certification for CE Mark – An Overview

By |2022-05-24T05:22:23+00:00May 24th, 2022|

The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in the European Union. For manufacturers of higher-risk devices (Class IIa, Class IIb, and Class III), involving a notified body in the conformity assessment process is mandatory; however, most manufacturers of Class I devices [...]

Is MDR Compliance Expensive?

By |2022-05-17T04:41:49+00:00May 17th, 2022|

The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations are changing, so is the cost to follow them. The new rules will force the industry to update its existing processes, which could come at a substantial cost. The question is, how [...]

Post-Market Surveillance and Vigilance: MDR vs IVDR

By |2022-05-09T21:38:27+00:00May 10th, 2022|

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 that will increase safety and efficiency in the European medical device market; both include collecting clinical evidence and demonstrating an [...]

Can Artificial Intelligence Technology Tame Literature Review?

By |2022-05-03T15:21:55+00:00May 3rd, 2022|

When one tries to publish in an international journal these days, they inevitably encounter an obstacle: researchers around the world have more than likely published thousands of papers on a similar topic, which could need an entire year to read through and database. And this problem is not only for scientists only. Any company or [...]

IVDR: General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices (IVDs)

By |2022-04-25T13:27:26+00:00April 26th, 2022|

A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say the implementation of the MDR has been complicated, for both manufacturers and the notified bodies. Even though the European Parliament voted for a partial delay of the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) in December 2021, the implementation [...]

The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs

By |2022-04-18T22:26:06+00:00April 19th, 2022|

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 objective of the literature search is to obtain information about the safety and performance attributes of similar products for which [...]

World Health Day – April 7, 2022

By |2022-04-05T17:37:45+00:00April 5th, 2022|

Initiated by the World Health Organization and celebrated by all, each April 7 is recognized worldwide as world health day! This April 7 is no different. Each year, on this day, the World Health Organization (WHO) focuses on an issue of particular concern for wellness and medicine.   The programs, measures, and health campaigns are [...]

Managing Clinical Evaluation Report (CER) and Literature Review Teams

By |2022-03-29T15:49:22+00:00March 29th, 2022|

Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up with a device that will be beneficial to the patient population, and hence will have a place in the target market, but also to ensure that the research regarding the product [...]

Using the IMDRF Classification to Apply Rule 11

By |2022-03-22T05:44:18+00:00March 22nd, 2022|

The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification of new or unknown software through an understanding and analysis of two critical aspects: How significant is the information provided? How critical is the situation or condition described? However, there are a few [...]

EU Clinical Trials Regulation and Reporting the Negatives in Clinical Trial Reports

By |2022-04-12T14:53:54+00:00March 15th, 2022|

The new clinical trial regulations that are in place right now will streamline applications and increase transparency.   The current clinical trials regulatory framework for the European Union (EU) has entered into effect this 31 January 2022.   The Clinical Trials Information Systems system (CTIS) is available to patients and competitors and the general [...]

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