Entering the EU Market: In Vitro Diagnostic Devices (IVDR)

The In Vitro Diagnostic Medical Devices Regulation governs diagnostic tests and the related devices. Its greatest difference from the earlier directive is that classification has moved from a list basis to a rule basis, and as a result most devices have come within the scope of a notified body.

The obligation lies with the manufacturer; for manufacturers outside the EU an authorised representative established in the EU is mandatory. A PRRC must be appointed.

• The device description, intended purpose and classification rationale
• Analytical performance data
• Clinical performance and scientific-validity evidence
• Stability and shelf-life studies
• The risk management file
• ISO 13485 quality management system records
• UDI information and EUDAMED registration

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• For sterile Class A and for Class B, C and D devices a notified body is involved
• For Class D, an EU reference laboratory and batch verification come into play
• Most devices that reached the market on self-declaration under the old directive are now within the scope of a notified body
• There is a conditional exemption for tests produced within a health institution

1. 01IVDR and MDRThe MDR covers devices acting directly on the patient, the IVDR devices making measurements on a specimen. Their classification logics and forms of evidence differ; a kit cannot be assessed under the MDR.
2. 02IVDR and laboratory accreditationISO 15189 qualifies the competence of a medical laboratory; the IVDR governs the conformity of the KIT the laboratory uses. The two assess different subjects.
3. 03IVDR and in-house produced testsThere is a separate arrangement for tests a health institution produces in-house and uses only on its own patients; this is a conditional exception rather than a full exemption.
4. 04IVDR and instrument standardsIEC 61010 addresses the electrical safety of a laboratory instrument; the IVDR looks for the reliability and clinical performance of the diagnostic result. Instrument safety is only one part of an IVDR file.

This page describes entry into the European Union market. The scheme itself — its scope, process, validity period and required documents — is covered in detail on the certification page.

This section's content is being prepared. The roadmap specific to your product and target market at the quote stage in writing.