MDR

This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now! Manufacturers across the world are not only planning to transition to the … Read more

On 5th May 2017 the new Regulation on medical devices (EU 2017/745) and a Regulation on in-vitro diagnostic medical devices (EU 2017/746) were published, these replace the existing Directives. These new rules will only apply after a transitional period, 3 years after entry into force for the Regulation on medical devices and 5 years after … Read more

There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to … Read more

The final draft of the Medical Device Regulation (MDR) clarifies what will be legally expected of health institutions, or by external parties on their behalf, who opt for the reprocessing of single-use devices. A single-use device, as is implied by its name, is a device which is intended to be used on a single patient … Read more

This article has been updated! Please visit the following link: https://www.advenaltd.eu/news/5935/reusable-surgical-instruments-in-eu-regulation-7452017/   The upcoming EU Medical Device Regulation brings with it several new device classification and one specifically involves Class I Reusable Surgical Instruments. Which are defined as: “an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar … Read more