Free EU MDR Templates – Download Here
Before you begin (or continue your EU MDR Journey), make sure you're operating off of comprehensive templates. This article will cover a…
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
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
A clinical evaluation report checklist for someone writing their own CER covers nine steps: scope and intended purpose, device and equivalence description,…
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
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
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The…
20 Nov 2025
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…
20 Nov 2025