I am thrilled to share some fantastic news with you!
Thanks to the tremendous effort of a group of hard-working, dedicated, and talented people, Adin achieved an incredible feat by becoming MDR certified to ensure maximum safety for our clients and demonstrate our unwavering commitment to quality, innovation, and excellence.
This certification is a more stringent set of regulations created to boost medical device safety and restore public confidence.
What is MDR?
The Medical Device Regulation (MDR) is a set of rules governing medical devices in the European Union created to boost medical device safety.
It has replaced the previous standard for medical device regulation in the EU, the Medical Device Directive (MDD), to improve device safety and transparency.
Fundamental changes include:
- Stricter evaluation processes.
- A risk-based classification system.
- More clinical evidence requirements.
- Better post-market surveillance.
It also introduces a unique device identification system for tracking devices.
The MDR governs the entire process of developing, manufacturing, and commercializing advanced medical devices.
Unlike the MDD, which focuses solely on product launch, the MDR considers the entire product lifecycle, including development, testing, manufacturing, efficacy, safety, and long-term use.
One of the significant distinctions between the MDD and MDR is the introduction of new safety requirements.
The MDR has expanded the pre-market requirements from 13 essential requirements in the MDD to 23 General Safety and Performance Requirements (GSPRs), which requires Adin, as a manufacturer, to allocate significant resources and effort.
Manufacturers must perform pre-market and post-market surveillance to ensure their products' quality, performance, and safety throughout their lifetime.
The new regulations put more emphasis on post-market surveillance and introduce strict requirements outlined in Articles 83 to 86 and Annex XIV of the MDR, along with several guidelines for implementation.
These activities confirm the clinical performance and safety of devices already on the market.
All collected data is analyzed and presented to the corresponding notified body for Conformity Assessment, as without proper post-market surveillance, Adin products will not meet European regulations.
Advancing Safety, Enhancing Transparency.
Our Regulatory Affairs team updated the technical documentation required for MDR certification, a project that lasted over three years.
The documentation included labeling and instructions for use in 17 languages, detailed design and manufacturing information, risk management plans, product verification and validation, and post-market surveillance.
Despite the daunting task, our team found motivation in their unwavering commitment to ensuring the safety of our products for our clients, whom we consider as family.
The project also fostered cross-departmental collaboration and learning, resulting in new concepts, insights, and even close friendships.
Our team's hard work, dedication, and expertise achieved MDR certification and raised our safety and quality assurance standards to even greater heights.
We are immensely proud of our team's achievements and are excited to share this news.
For Adin's certificates: Click Here
