EU IVDR

Person Responsible for Regulatory Compliance (PRRC) under EU MDR/IVDR

Regulatory Compliance / By / 7 minutes of reading /

EU MDR (2017/745)1 and EU IVDR (2017/746)2, Article 15, both stipulate specific activities that must be carried out within a manufacturer’s organization by a person responsible for regulatory compliance (PRRC) who fulfills minimum conditions of qualification. In this post I will cover the following related to PRRCs: As we’ll see, the MDR requirements are fairly […]

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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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Does EU MDR require on-site supplier audits?

Regulatory Compliance / By / 5 minutes of reading /

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

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