September 27, 2022
The European Medical Device Regulation (MDR) outlines the requirements for the literature review needed for the clinical evaluation of medical devices. You need a robust process for performing your literature review and finding clinical [...]
February 8, 2022
No matter how hard you try as medical device manufacturer to make sure your device is safe and efficient, adverse events can still happen. Even the most vigorously tested medical devices have adverse [...]
February 3, 2022
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]
February 1, 2022
For manufacturers, clinical trials or at least the protocol are already planned and set to go for up to 2023. However, a new development in the clinical trials regulation means what you [...]
January 27, 2022
Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. [...]
January 26, 2022
There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously [...]
January 18, 2022
Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness of your product is the first step of proving its quality attributes. [...]
January 11, 2022
The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]
January 3, 2022
The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]
December 28, 2021
While larger manufacturers, global players, and multinational companies most likely won’t have problems complying with the European MDR due to having both the financial and human resources to comply in time, smaller and medium-sized [...]