Medical Devices

On the 5th of April 2017, the European Union adopted two new regulations on medical devices and in-vitro diagnostic medical devices. These regulations, which entered into force on the 25th of May 2017, are set to progressively replace the existing directives. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) have been introduced to ensure a higher standard of safety and performance for medical devices across the EU. These new regulations will replace the three existing medical device Directives: 93/42/EEC, 98/79/EC, and 90/385/EEC.

At Pharmaconsulta, we are well-equipped to assist you in navigating these significant regulatory changes. Our services include upgrading your Quality Management System (QMS) to meet the new requirements and auditing your products for compliance with the MDR and IVDR. Our expert team will ensure that your devices meet the stringent safety and performance standards mandated by the new regulations. We provide comprehensive support, from the initial assessment of your current QMS and product portfolio to the implementation of necessary upgrades and modifications. Our goal is to ensure that your products are fully compliant with the latest EU regulations, allowing you to continue marketing them within the European market without disruption.

Partnering with Pharmaconsulta means leveraging our extensive experience and deep understanding of the regulatory landscape. We are dedicated to helping you achieve and maintain compliance, ensuring that your medical devices meet the highest standards of safety and effectiveness.