Archive for June, 2009
Drug or Device? – MHRA issues updated guidance on borderline cases
Directive Bulletin 17 provides updated guidance on the regulatory criteria for considering drug/device borderline products. It also contains a very useful appendix that lists a number of products and clarify’s their classification depending on intended use or mode of action.
European Commission loses patience with additional Italian registration requirements
We’ve reported previously on the Italian Health Ministry’s controversial Repertorio system which requires non Itailan device manufacturers to register their products on a database. Well the EC has now decided to take infringement proceedings against Italy regarding the additional requirements on the basis that they go beyond EU law and put non Italian device manufacturers at a disadvantage as they are difficult to comply with. The deadline for device manufacturers to comply with the additional requirements had already been put back to December 2008 but perhaps now they’ll end up being scrapped?
MHRA fee increases
The MHRA has confirmed that it has increased the fees it charges notified bodies and medical device manufacturers with effect from 1 April 2009. The increases reflect the increased amount of resources that are being allocated by agency staff to this activities. You can find a document outlining the new fees here.
Italian Repertorio deadline extended
We’ve been working with a number of device manufacturers recently regarding the new requirements for device registration in Italy which involves entering product information on a database and validating this information using an electronic signature (Smartcard).
As with any new system it has its teething problems and we’ve just heard that the deadline for registration and coding of devices in the system , “the Repertorio” has been extended once again to 31 December 2009. This extension enables all medical devices to still be sold despite not having the code required by the Italian legislation that was first introduced in 2007.
This provides manufacturers with a little breathing space but they still need to get their products on the register by the end of the year.
For assistance with the registration of medical devices in Italy please feel free to contact us!
European Commission to push ahead with recast?
In summer 2008 the European Commission revealed plans to “recast” the medical device regulatory framework in Europe (find document here). Following feedback from industry implementation was postponed but it now appears there is a move to pursue the recast.
At a recent device industry meeting in Rome Georgette Lalis, Director of the European Commission consumer products and industry division confirmed that “we will eventually deliver, under the new commission, a broader revision of the medical devices regulations in Europe”. It appears that the commission aims to have the new framework in place by 2015. A lot can obviously happen between now and then but we think one thing is for certain and that is there will be fundamental changes to the regulatory environment for medical devices in Europe over the next five years.
The end of the road for the Global Harmonisation Task Force?
Now that the GHTF is on the verge of releasing its mission of producing a global regulatory model it appears that there is considerable uncertainty over whether the task force should continue, or at least that would appear to be the noise coming out of its 2 day meeting in Canada last month.
The options seem to be to either close it down, keep it going in its current format or restructure now that the global regulatory model is on the verge of being published. We don’t think any decisions have formally been made and we’ll post more news as soon as we get it.
More information on the goals and objectives of the GHTF may be found here.
Richard Young joins the Mediqol team
I’m delighted to be able to announce that Richard Young will shortly be joining the Mediqol team.
Richard joins us from Renishaw Neurological Products and has MDD, AIMDD and IVD experience in Europe, the USA and some ROW markets. Richard has over 15 years medical devices experience with companies such as Zimmer, Alaris Medical and Plasma Surgical and we are very much looking forward to letting him utilise this experience with our clients.
