#asuntosregulatorios #regulatoryaffairs #dispositivosmédicos #medicaldevices #comercializardispositiovsmédicos #medicaldevicemarket #biocidas #biocidas #comercializarproductosmédicos #marketmedicaldevices
The European Medical Device Regulation (MDR) is legislation that regulates medical devices in the European Union (EU). The main difference between the current MDR and its previous version lies in the improvement of regulation to guarantee the safety and effectiveness of medical devices, as well as transparency and traceability throughout the manufacturing, marketing and use of these products.
Some of the key differences between the current medical devices MDR and the previous MDD (Medical Devices Directive) include:
Expanded Scope: The Medical Devices MDR expands the scope of covered medical devices, including products that were previously unregulated or subject to less stringent regulations, such as in vitro diagnostic devices.
Conformity assessment: The MDR for medical devices establishes more rigorous requirements for the conformity assessment of medical devices, including greater involvement of notified bodies and a more comprehensive evaluation of clinical data.
Post-market surveillance: Post-market surveillance requirements are strengthened to quickly detect and respond to any safety or effectiveness issues with medical devices once they are on the market.
Unique identification: The MDR for medical devices requires the assignment of a unique identifier to each medical device to improve traceability throughout the entire supply chain and facilitate product recall in case of problems.
Clinical data: Stricter requirements are established for the collection and evaluation of clinical data to support the safety and effectiveness of medical devices, especially for higher risk products.
Manufacturer responsibility: Manufacturers' responsibilities are reinforced in terms of product quality and safety, as well as in the management of post-marketing information and cooperation with regulatory authorities.
In summary, the MDR for medical devices updates and strengthens the regulatory framework for medical devices in the EU to address the challenges and technological advances in the sector, ensuring greater protection for patients and users of these products.
For more help