Archive for September, 2009

BSI acquires German Notified Body

posted by Colin Rylett
Tuesday, September 22, 2009

BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .

BSI adds to Fast Track service offering

posted by Colin Rylett
Tuesday, September 22, 2009

BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.

CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th  such initiative BSI have introduced in the last couple of years and in a market where speed to market is key it will prove attractive with device manufacturers although it should be noted that such a service comes at a premium cost.

The Drug Tariff – disallowed products

posted by Colin Rylett
Friday, September 11, 2009

A listing on the UK Drug Tariff allows manufacturers of certain medical devices to provide their products over the counter in pharmacies and gain direct reimbursement for the product. This link http://bit.ly/TtLbB takes you to the PSNC web-site which provides a listing of all those products which are disallowed products.

Over the years we’ve helped lots of clients get their products listed on the UK Drug Tariff. For details of how we can help please email kevin.webb@medqol.com