CE Marking

What are Common Specifications under EU MDR and IVDR?

Regulatory Compliance / By / 7 minutes of reading /

The quick answer to this question is a Common Specification (CS): “means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.”1 Essentially, the European Commission has reserved the right within both EU MDR1 and EU IVDR5 […]

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What are harmonized standards under EU MDR and EU IVDR?

Regulatory Compliance / By / 4 minutes of reading /

The quick answer to this question is a harmonized standard (or “harmonised” standard in EU regulations), “means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation”1. While this sheds some light on the title question, in this post, I will answer in a

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