Europe: EU IVDR Compliance for Manufacturers of Laboratory-Developed Tests and In-House IVD Tests

ARQon
Dec 17, 2021
2 min read

Manufacturers of in-house lab-developed tests (LDTs) or in-house in vitro diagnostics (IH-IVDs) have had it quite easy when it comes to complying with European regulations, same goes to other IVD manufacturers. On 26 May 2022, this will come to an end. While the EU's In Vitro Diagnostic Directive (IVDD 98/79/EC) exempted manufacturers of so-called in-house testing (also known as LDTs), the new In Vitro Diagnostic Regulation (IVDR 2017/746) does not. Despite the fact that there isn't a single mention of LDT in the IVDR, and no guidance materials have been released as of October 2021, many manufacturers are scratching their brains as to what is now required and what should be done next.

Types of in-house tests

1. Tests created and administered by a health institution (eg. biopsy tissue sample). While a health institution is putting an IVD "into service," it is not putting the IVD "on the (EU) market." Article 5 of the IVDR outlines the standards for these health institutions

2. Testing services, which include sending a sample to a lab and receiving a result. Testing services are covered by Article 6 of the IVDR, which deals with distance sales, and are treated the same way as if the IVD were sold commercially on the market.

Focus of Article 6 of the IVDR

1. Although the IVDR does not define or specify so-called LDTs, they are covered by it.

2. An in-house IVD must have no CE Marked IVD on the market in order to be excluded from CE Marking.

3. LDTs / in-house IVDs are classified using the same classification system as IVDs.

3. The location of the testing has no bearing on compliance.

4. At the very least, all testing must adhere to the General Safety and Health Regulations and Performance Requirements as per in the IVDR's Annex I.

6. An LDT / in-house IVD should be classified using the IVDR classification rules specified in IVDR Article 47 and Annex VIII.

7. While ISO 15189 will suffice for a health institution, ISO 13485certification may be required for testing services.

Compliance of IVDR Commercial IVD Testing Services

Table below shows criterias/information to comply for in-house tests where the samples are collected in EU and sent back to a testing facility inside or outside EU.

Review area Requirement General Safety and Performance Requirements Required, see Annex I CE Marking of Test Required, regardless of where actual testing is done IVDR Classification of Specimen Receptacles Class A IVDR Classification of Tests Class B, C, or D Performance Evaluation Required, see Article 56 and Annex XIII Post-market Surveillance (PMS) Required, see Articles 78-79 and Annex III Corrective and Preventive Action (CAPA) Required under Annex I Quality Management System Compliance ISO 13485 is essential Exemption for Research Use Only (RUO) Products Must have no medical purpose