Blog & News
Our articles and news about our medical devices.
EC Certificate Directive 93/42/EEC
In our commitment to providing safe and efficient medical devices, we align with internationally recognized standards. One such standard is Directive 93/42/EEC (also known as MDD), a European Union directive that sets the framework for marketing medical devices. To...
Newsletter 1 : Vitrobio Certification Update
2017/745 Regulation (MDR) – Vitrobio Certification Update Vitrobio is already committed to the transition to MDR. An application for certification under Annex XI part A of Regulation 2017/745 has been submitted to the GMED, for the entire product portfolio....
Vitrobio ISO 13485 certificate
In our ongoing commitment to delivering safe, efficient, and reliable medical devices, we place great emphasis on adhering to globally recognized standards. A key example of this is our certification to ISO 13485, an international standard that specifies requirements...
Confirmation letter of certification application framework of regulation (EU) 2017/745
We understand the value of transparent and clear communication with our clients, especially when it comes to compliance with regulatory standards. For all our partners who distribute our medical devices, we want to provide assurance of our commitment to meeting the...
Delving into the World of Medical Devices: An Overview with a Focus on Class IIa Nasal and Throat Sprays
Understanding Medical Devices, their Classes, Market Dynamics, and a Deep Dive into the Production of Class IIa Nasal and Throat Sprays Medical devices form an integral part of the healthcare industry, spanning from simple tools like bandages to complex...
Navigating the Transition from MDD to MDR: Legacy Devices and Marketing Authorization
Implications of the Extended Transition Period and How it Impacts Legacy Devices and Their Marketing Authorization The evolution of the regulatory landscape in the medical devices sector has witnessed a notable transition from the Medical Devices Directive...
Understanding the Medical Device Regulation (MDR 2017/745): A Transformative Shift in the Medical Device Industry
Exploring the Origins, Implications, and Future Impact of the MDR for Stakeholders in the Healthcare Sector The healthcare landscape is ever-evolving, with regulatory frameworks often adapting to ensure safety and efficacy of medical devices. One such...