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So far admineu has created 7 blog entries.

Clinical Evaluation Literature Search

The basis of your device CERs is Literature Search. If you're in charge of compliance for a number of goods, you're well aware that EU MDR presents a significant challenge to your team and current timeframes. If you're a smaller manufacturer, you're probably just dealing with one or two people who are responsible for [...]

By |2021-12-20T12:09:00+00:00September 2nd, 2021|UK CA|0 Comments

Medical Device Labelling

Medical Device Labelling: A label is the written, printed, or visual information that appears on the medical device itself, as well as the packaging of individual units or numerous medical devices. To avoid non-compliance, manufacturers must ensure that their product labels include all of the following elements: Name of the device The serial number [...]

By |2021-12-20T12:26:50+00:00September 2nd, 2021|EU CE|0 Comments

What is 510k summary?

The 510(k) summary is an abstract of the details related to the proposed device included in the 510(k) file and the supporting information. This document will include details about the device, manufacturer, predicate device chosen and substantial equivalence comparison with the predicate device selected. The details of the various nonclinical tests and clinical trials [...]

By |2021-10-03T09:06:25+00:00August 12th, 2021|US FDA|0 Comments

User Manual Requirements for Medical Devices

A information supplied by the manufacturer to inform the user of a product's intended purpose and appropriate use is referred to as "instructions for use." The following items must be present in the information provided with the directions for use: Information in line with Section 23.2 of the MDR points (a), (c), (e), (f), [...]

By |2021-12-14T10:51:30+00:00July 2nd, 2021|EU CE|0 Comments

Single Registration Number (SRN)

What exactly is a Single Registration Number (SRN)? The Single Registration Number (SRN) is a unique code that is used to identify an economic operator in the EU without ambiguity. The SRN number is generated by EUDAMED and issued by the competent authority who validated the Actor registration request in EUDAMED. Manufacturers must apply [...]

By |2021-12-20T12:06:28+00:00July 2nd, 2021|EU CE|0 Comments

Eudamed Actor Registration

All economic operators in the European territory and non-EU manufacturers, authorized representatives, system/procedure pack producers, and importers must register as an actor in EUDAMED and provide the required data. The actor registration module of the European Commission's Eudamed database, which is a critical component of the EU's Medical Devices Regulation (MDR) and In Vitro [...]

By |2021-12-20T11:58:20+00:00July 2nd, 2021|EU CE|0 Comments

Attributes of Biological Evaluation

B Biological Evaluation is estimation of biological responses of the product to ensure safety and efficacy with patient and user. Biological Evaluation of Medical Devices is a series of tests performed with the help of international standards pre-clinically either through In-vitro or In-vivo techniques and may upon animal models to assess the biological safety [...]

By |2021-12-14T11:06:54+00:00June 22nd, 2021|EU CE|0 Comments
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