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 […]
What are Common Specifications under EU MDR and IVDR? Read More »
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
What are harmonized standards under EU MDR and EU IVDR? Read More »
If your organization currently markets or plans to market medical devices within the EU, you may be wondering if EU MDR1 or EU IVDR2 requires on-site audits of your suppliers. EU MDR/EU IVDR does require notified bodies to consider the need for both announced and unannounced audits of your suppliers depending on risks associated with
