1st August 2023 UK Government announces indefinite extension to CE marking > Read More...
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Summary

At the same time as the EU MDR (2017/745) came into force, so the EU IVDR  (2017/746) also superseded the old IVD directive, which had become unfit for purpose due to significant advances in technologies and within the Medical Device industry. The EU IVDR came fully into force in 2017 and introduced a significantly more stringent regulatory environment for in vitro diagnostic medical devices.

The IVDR covers equipment (including receptacles) intended by the manufacturer to be used to in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information e.g. concerning a physiological or pathological process or state, on the predisposition to a medical condition or disease, the safety and compatibility of a process with potential recipients or to predict treatment response or reaction.

 

 

See our new In-Vitro Diagnostic Medical Devices Directive page for the UK

Introduction to CE and UKCA Marking your Products

This course will guide you through the complete CE marking process, from design considerations and finding the right standards to completing all the necessary documentation.

Read more: Introduction to CE and UKCA Marking your Products

CE and UKCA Marking Machinery & Industrial Equipment

This course will give you an understanding of how to carry out machinery assessments, including finding and applying the relevant standards, and the documentation that must be provided.

Read more: CE and UKCA Marking Machinery & Industrial Equipment

Machinery Risk Assessment Training

This course explains the role of standards in the risk assessment process, to enable designers and project managers to carry out the risk assessment in the most efficient way.

Read more: Machinery Risk Assessment Training

Pressure Equipment Directive Training Course

This course provides an overview of the Pressure Equipment Directive, where you will learn who should take responsibility, how to find and apply standards, what documentation you need to produce.

Read more: Pressure Equipment Directive Training Course

ATEX Compliance & Risk Assessment Course

This course will take you through the CE and Ex marking process in detail. You will gain an understanding of the requirements, including the various options for ensuring equipment is safe.

Read more: ATEX Compliance & Risk Assessment Course

CE & UKCA Marking Electrical Equipment Training Course

This course will explain who is responsible for CE marking, and what should be done to carry out the process correctly, as well as looking into the directives and standards involved.

Read more: CE & UKCA Marking Electrical Equipment Training Course

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