Recently Priory Analysts had a case where, since there was no GMDN code for the particular medical device, the manufacturer had attempted to make 'classification adjustments' in order to notify some Authorities. Part of the problem stems from the ownership of the GMDN, and the relative cost of obtaining and using a code. This is not to deny the need for the owners of the GMDN to cover their costs.

The EU Medical Devices Directives state: ‘Name and address of the manufacturer (and EU Authorised Representative) on the product label and instructions for use’.

Device 'approvals' come under scrutiny yet again. Medics, the media, regulators and who knows whom else, opinionate on the lack of clinical trials on devices compared to the amazing world of pharmaceuticals.

NICE stands for 'Next Invoice Christchurch Earthquake.' Should you do business in Christchurch why not do the NICE thing, and donate all or part of your next invoice to the Christchurch Earthquake Appeal Fund. This is a challenge to those firms which do business in Christchurch and New Zealand, like Priory Analysts. However, it is not an exclusive club! Be NICE. Make a difference.

In 1998, the In vitro diagnostics device directive required that the establishment of European databank. 13 years later, with assistance from yet another Directive, 2011 could be the year for EUDAMED. The database prompts the need for GMDN. The current fee structure for use of the GMDN needs serious revision if EUDAMED is going to work. 

... because 510(k) is a section of the Federal Food, Drug and Cosmetic Act, and as such can only be amended by another Act. FDA may amend the execution of part 510(k) - but not eliminate it.

The 'substantially equivalent' requirement of the 510(k) notification is excellent for 'me-to' medical devices, for which surely the notification method was originally established. On the other hand, the EU system is more clumsy with 'me-to' devices. When it comes to new technologies and new devices the reverse is true. We need to learn from each other.

But so often they are viewed as a 'necessary evil' for those involved in the healthcare industry.

Thank you for visiting this re-created website. A special thanks to Jamjar Creative for their work. (Go to ‘Contact Us’ and select the ‘Useful Links’ page to find them).

The blog is a new feature. We plan to update it monthly, which will coincide with the monthly update on the EU Regulatory Affairs Update service, Regae-paCE.

Watch this space!