We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy. Learn more here.Close Me
Apart from some corrections of lay-out, there are two
corrections of relevance:
First, there was a minor modification to the way that the
instructions for use could be obtained. Rather than the general
obligation on the manufacturer explain how and when the
instructions for use can be obtained, this explanation must now be
given in the paper IFU (see article 6 (3) (d)).
Secondly, the date as of which the regulation will apply is now
known. Although it looks like the regulation will still enter into
force end of this year, it will apply as of 1 March 2013.
With this date manufacturers have a clear horizon for planning of
implementation of e-labelling.
Not all companies are happy with this and the general feeling
that I perceive from my contacts in the medical devices industry is
that this proposal is a big disappointment first and foremost
because of the very limited scope of application. Also, there is
fear of borderline problems: for example, the concept of 'fixed
installed devices' in article 3 (1) (c) is less than clear and
makes the situation of devices that used to fixed becoming mobile
(like CT scanners, X-ray devices) very unclear. I hear a lot of
criticism about the manufacturer's one-sided obligation to do
risk management to ascertain if a hospital can handle e-labelling.
This is of course a moving target because hospitals are normally
not at all amenable to giving the manufacturers any degree of
control over and full insight in risks at the hospital side in this
respect. That makes risk management a moving target and basically a
mission impossible, not to mention an additional regulatory
requirement that is not imposed by the Medical Devices
Directive.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Under the NHS reforms, CCGs now have responsibility for commissioning healthcare services to meet the reasonable needs of the persons for whom they are responsible.
The main purpose of this brief information note is to indicate the regulations of healthcare services and health insurances available for foreigners in Turkey
Leaders from some of the South West’s biggest and most successful industries have come together to draw a road map to the region becoming Britain’s agri-food sector ‘centre of excellence’.
Parallel to the harmonisation process of Turkish legislation with European Union law, the legal environment regarding veterinary products is also evolving in Turkey.
There have been specific rules governing the promotion of medicinal products in Turkey since the beginning of the 90’s.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
