The Role of the Pharmacist under IVDR Regulation

The Pharmaceutical as a link between the Hospital and the Industry in the IVDR scenario

Did you know that the pharmacist is increasingly prepared to work both in the hospital environment and in industry, especially with the evolution of regulations such as IVDR (EU 2017/746)?



In the hospital environment, the pharmacist has a fundamental role in the evaluation and management of medical devices for in vitro diagnosis. It participates in the selection, clinical validation, storage, traceability and safe use of these products, ensuring that they comply with the new requirements of clinical performance, scientific evidence and patient safety. This performance requires technical-regulatory knowledge and critical vision based on data and evidence.

In the industry, the pharmacist acts directly in the implementation of the IVDR, contributing to the development of regulatory strategies, preparation of technical documentation, performance evaluation plans, risk management and interface with notified bodies and regulatory authorities. Here, the focus is to ensure that the product reaches the market with quality, safety and compliance - and remains so throughout its life cycle.

The pharmacist's solid training in good practises, quality control, validation, pharmacovigilance and regulations allows him to transit competently between the two worlds. This versatility is one of the greatest strengths in our field of activity.

The future of health is interdisciplinary and regulated - and the pharmacist is ready for this challenge.

#IVDR#HospitalPharmacist#IndustrialPharmacist#MedicalDevices#RegulatoryAffairs#HospitalPharmacy#QualitySystems#MedicalDevices#HealthTech#Compliance #Pharma

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