Module Overview

Quality and Regulatory Pathways for IVDs

The module aims to provide the learner with a comprehensive understanding of quality principles and practices, clinical evaluation and regulatory pathways to bring in vitro diagnostic medical device (IVD) and companion diagnostic products to market for clinical and diagnostic purposes.

Module Code

BIOL 4010

ECTS Credits


*Curricular information is subject to change


International standards for quality in the context of an IVD and Biobanks (e.g. ISO 15189, ISO 22870).

Agencies responsible for accreditation and ensuring competency (e.g. HPRA).

Key components and benefits of Quality Management Systems (QMS) in supporting quality.

Risk-based approach to quality and the requirements.

Internal Quality Control (IQC) and External Quality Assurance (EQA) schemes.


Regulation of IVDs

Classification of IVD devices in accordance with IVD legislation – IVD Directive 98/79/EC, IVD Regulation 2017/746/EU, Federal Food, Drug, and Cosmetic Act, section 201(h).

Overview of the legislation and regulatory pathways for IVDs. Role of the EU Commission, Competent Authorities, FDA, Notified Bodies, IVD manufacturers and users.

Placing an IVD on the market – clinical performance evaluation and conformity Assessment pathways for CE marking and FDA (510K) approval of IVDs

Post market surveillance of IVDs

Regulatory challenges for scientific advances and emerging technologies in IVDs


Clinical Trials

Purpose, definition & phases of clinical trial: First-in-Human studies, phases I-IV, outcome measures.

Clinical trial design: clinical trial protocol, randomised trial designs: parallel, group, cross-over, matched pair, withdrawal & factorial design; stratification; non-randomised trial design, adaptive trial design examples; patient centeredness in design of clinical trials

Good Clinical Practice: history; 13 principles of GCP guidance; GCP standards

Clinical Trial Regulation No.536/2014; Clinical Trial Directive 2001/20/EC

Drug-Diagnostic Co-Development: Companion diagnostic (CDx) analytical and clinical validation. Examples of clinical trial designs for parallel development of drug & diagnostic: all-comers, enrichment & biomarker stratified design. Comparative analysis of global regulatory pathways for CDx

The course will be delivered over 25 contact hours including lectures, workshops, web-based materials, case studies involving class discussion and participation. A total of 75 hours self-directed learning is required and tutorial/review sessions will also be provided.

Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)100