New deadline for the certification of medical devices under the Medical Devices Regulation (MDR)
On 7 March 2023, the Council adopted a regulation that extends the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). The measure aims to allow the MedTech industry to continue to bring essential equipment to the market and ensure that patients have safe access to medical devices. Key points The […]
Globalizing Smiles: Dentistry and Localization
Globalizing Smiles: Dentistry and Localization A healthy picture-perfect smile has become a top priority and a beauty standard across the globe, partly motivated by celebrities and the vanity culture developed with social media. However, worldwide we can witness an increase in the prevalence of dental disorders due to smoking, aging, and poor oral hygiene. This, […]
Certified Translation of Instructions for Use for Medical Devices
The primary objective of the translation is to provide users with clear and understandable guidelines for properly using medical devices. The most important aspect to keep in mind involves legal issues. Countries in the European Union dictate that the proper translation of instructions of use is a mandatory requirement. The translation is essential for avoiding […]
New European Union Medical Device Regulation
What is MDR? The MDR is the new regulation for medical devices and sanitary products. Its main objective is to establish new requirements for the production and supply of medical devices in European territories while meeting high quality and safety standards. It appeared in response to the need for updated measures established by the Medical […]
