Meddev 2.7 1 Rev 4: Guidelines for Literature Search
MEDDEV 2.7.1 Rev. 4 remains the most important technical guidance document for conducting literature searches within the European medical device regulatory framework.…
20 Nov 2025
PMCF Plan EU MDR: What You Need and How to Create It
Post-market clinical follow-up, or PMCF, is the proactive, ongoing collection of clinical data on a device after it reaches the EU market,…
20 Nov 2025
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in…
20 Nov 2025
Term Refinement in Literature Search
A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references…
20 Nov 2025
The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?
So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing…
20 Nov 2025
The UK MDR and The EU MDR: What Are The Differences?
The single biggest difference is that they are no longer the same regulation. Great Britain runs on the UK Medical Devices Regulations…
20 Nov 2025
What Is a Legacy Device, and What Do Manufacturers Need to Know About It?
The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions…
20 Nov 2025
Systematic Literature Reviews
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021,…
20 Nov 2025