MDR

There is considerable uncertainty regarding the commercial impact of Brexit and how this will affect medical device manufacturers who CE mark devices and use a UK based EU Authorised Representative (EC REP) and label their devices with a UK address. Here at Advena we track the UK political news closely and feel now that unless … Read more

A Reusable Surgical Instrument is defined as: “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.” – … Read more

Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! … Read more

A Major UK based Notified Body recently issued a major non-conformity to a medical device manufacturer in South Africa.   The auditor was not satisfied with the arrangements in place between the manufacturer and their EU Authorised Representative (EC Rep), in particular that their EC Rep was not a member of the European Association of … Read more

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