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New European Borderline and Classification Manual Published

EMERGO KEY POINTS:

  • An updated version of the European Borderline and Classification Manual for medical devices and IVDs is now published.
  • The latest manual will be of limited use once the European Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) go into effect because of different definitions and classification rules.

European Borderline and Classification Manual version 18 for medical devices and IVD productsEuropean regulators have issued the latest version of their Borderline and Classification Manual for medical devices and IVDs.

The manual, issued in its 18th version by the European Commission’s Medical Devices Expert Group on Borderline and Classification in December 2017, includes all previous cases as well as clearly marked new cases.

The manual represents a common understanding of the Medical Devices Directive and the In-Vitro Diagnostics Directive between European national Competent Authorities and industry stakeholders. However, the document should be regarded as guidance, not law. The manual may be referred to in product status or classification rationales, for example.

The value of the new manual for the upcoming Medical Devices Regulation and In-Vitro Diagnostics Regulation is limited, because the definitions of devices as well as classification rules have changed.

Additional European medical device and IVD regulatory information:

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