The General Data Protection Regulation (GDPR) is a comprehensive privacy law enacted in the European Union in 2018. It applies to all organizations that process the personal data of individuals located in the EU, regardless of where the organization is located.
CE marking is mandatory for all devices that are to be sold in the European Union (EU) countries. Similarly, In Vitro Diagnostic (IVD) devices must also obtain a CE marking and undergo a rigorous approval process to demonstrate their safety and efficacy. They have to abide by the requirements mentioned under the EU In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Each device has a specific set of requirements and procedures that they need to follow. In fact, the Regulatory requirements can be complex and challenging to follow.
With the implementation of the European Union (EU) In Vitro Diagnostic Devices Regulations (IVDR) 2017/746, the Performance Evaluation Report (PER) has changed dynamically in terms of its requirements and approach.
In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?
One of the time-tested ways is the use of medical device symbols. It can convey a significant amount of information in a small space. Although it is optional, using symbols on the labeling of medical devices is strongly advised. It offers benefits to both users and manufacturers, such as:
As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls and lead to costly delays.
Therefore, the key is to carefully prepare the medical devices labels aligning with the EU MDR labeling requirements, such as:
The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply feasibility.
In the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020. Considering the current global scenario and the shortage of devices and other medicinal products, the EC deemed it necessary to focus on ensuring the adequate supply of devices, as usual, instead of stressing more on the transition of the EU MDR.
To ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the transition period for medical device manufacturers will come to an end from May 26th, 2021, organizations must relook at implementing compliant processes and procedures accordingly.
With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region. With the growing concerns about the weaknesses in the current system, the European Union (EU) was in plans to implement tougher rules governing the safety and monitoring of medical devices.
