Frequently Asked Questions

• Can our laboratory continue using LDTs after the IVDR deadlines?

  Yes—if you are an EU health institution and meet all six conditions of Article 5(5), including justification of unmet need, ISO 15189 compliance, GSPR alignment, and publication of a declaration. MDx provides full support across documentation, QMS updates, and regulatory strategy.

• What’s the difference between an in-house IVD and a CE-marked test?

  An in-house IVD is manufactured and used solely within a single health institution and not placed on the market. CE-marked devices are commercial products approved for wider distribution under IVDR. MDx helps labs define and classify their assay portfolio and determine eligibility under Article 5(5).

• What are the IVDR requirements for US labs (CLIA/CAP) testing EU patient samples?

  US labs offering diagnostic services to EU citizens must comply with Article 6 of the IVDR. This includes full technical documentation, GSPR conformity, PRRC designation, and CE-marking via a Notified Body. MDx helps non-EU labs establish regulatory pathways and retain EU access.

• Is ISO 15189:2022 sufficient for IVDR compliance?

  Not by itself. While ISO 15189 is mandatory, MDCG 2023-1 confirms that a complete QMS must also address risk management (ISO 14971), manufacturing controls (ISO 13485), and post-market monitoring. MDx delivers integrated QMS frameworks tailored to IVDR expectations.

• How do I justify that no equivalent CE-IVD exists for our in-house test?

  The justification must be based on clinical, technical, or biological criteria and supported by a structured market assessment (e.g., EUDAMED review). MDx builds your justification files and GSPR checklist in line with Article 5(5)(d) and Annex I.

• What do I need to do if our in-house test falls under Class D?

  Class D in-house IVDs require enhanced technical documentation similar to CE-IVD Annex II requirements, including detailed performance data. MDx provides support with performance evaluation plans, analytical/clinical data, and PMS strategies.

• Can non-CE marked assays be used in clinical trials?

  Yes—EU labs may use local tests under Article 5(5), while non-EU labs or sponsors using unapproved IVDs must apply for a performance study authorization under Article 58. MDx supports both routes and develops harmonized protocols for combined CTR + IVDR studies.

• What happens if our public declaration or GSPR file isn’t ready by the 2024 deadline?

  You risk non-compliance, which could result in removal of your test or inspection findings. MDx ensures your declaration, justification, and GSPR documentation are complete, published, and ready for competent authority review.

• Are there differences in how Article 5(5) is enforced across EU member states?

  Yes. While the core IVDR requirements are EU-wide, enforcement and interpretation can vary. MDx helps navigate local competent authority expectations and national requirements to ensure consistent compliance.

Frequently Asked Questions

• What's included in a biological evaluation report?

  Our ISO 10993-compliant reports include material evaluation, including the type and duration of body contact, as well as potential biological risks. They include a review of existing data, material characterization, and toxicological risk assessment. Where applicable, additional testing to address required biological endpoints can be conducted – all coordinated with accredited test labs.

• How long does MDR certification typically take?

  Most devices achieve certification in 6-18 months. Our phased approach reduces timelines by 40% through parallel documentation/validation processes.

• What distinguishes your PMCF services?

  We implement risk-based PMCF strategies combining literature reviews, registry studies, and real-world data analytics to minimize clinical trial costs.

Frequently Asked Questions

• How does an IVD CRO run ISO 20916 clinical performance studies?

  We scope endpoints and study design, develop protocols and eCRFs, qualify sites, monitor conduct, manage data and biostatistics, and compile clinical evidence for the performance evaluation report. Our approach aligns with IVDR Annex XIII/XIV and Notified Body expectations.

• What does an IVD CRO do?

  An IVD CRO designs and executes analytical and clinical performance activities, prepares technical documentation, and supports IVDR and FDA submissions. At MDx CRO, we integrate regulatory, biostatistics, site management, and quality to deliver ISO 20916-compliant evidence for CE marking and U.S. approvals.

• Are clinical studies required for EU IVDR compliance?

  Not always. Under EU IVDR, clinical performance must be demonstrated through one or more of the following sources:

  • Clinical performance studies (Annex XIII & Annex XIV),

  • Scientific literature relevant to the device’s intended purpose, or

  • Published experience from routine diagnostic use.

  Manufacturers must plan this evidence in the Performance Evaluation Plan (PEP) and summarize it in the Clinical Performance Report (CPR) and Performance Evaluation Report (PER). While not all IVDs require a new clinical study, at least one of these sources must be available and sufficient to support the claimed clinical performance.

• Can MDx support LDT-to-IVD transitions?

  Yes, we help labs and test developers convert LDTs into compliant IVDs with support on documentation, validation, and market pathway selection.

• How long does CE marking typically take?

  Most clients reach CE mark readiness within 6–18 months depending on risk class, data readiness, and notified body availability.