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CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
The European Union Medical Device Regulation (EU MDR) has set higher standards for medical device clinical evaluation ERs) standards. With stricter regulations and guidelines, clinical evaluation report writing requires expertise, experience, and knowledge of the [...]
IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices
With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements for clinical evidence were increased by the regulatory authorities. 1 Part of [...]
Your Medical Device Got CE Marked – Now What?
Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The PIP breast implant scandal brought to light weaknesses in the overall regulatory process [...]
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in vitro diagnostic regulation. While the medical device regulation did not suffer [...]
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is?Your clinical literature review.Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation report assesses a [...]
How to Find The Best CER Medical Writers & Strategy
Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? Then this article is for you. With the transition to the [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical [...]
Vigilance Reporting Under the MDR: Insider’s Guide
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 UK MDR and The EU MDR: What Are The Differences?
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 [...]
Top Regulatory Updates in 2022: New Documents, Regulatory Scandals, and Useful Information
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 [...]
How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR
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 [...]