Media Centre :: Press Releases
01/01/02
MDA head confirms Department of Health guarantee
London. 'The Medical Device industry will not be
compromised by the proposed merger of the MDA/MCA. There will
continue to be two distinct sectors and the new agency will instead
be better able to respond to new challenges' David Jefferys, Chief
Executive of the MDA said on Monday.
He guaranteed the amalgamation would not cause a change in UK
medical device regulation and most importantly there would be no
new fees for manufacturers of medical devices, a present feature of
the medicines industry.
The Association of British Health-Care Industries
welcomed this confirmation. Director-General Gordon C. Aylward
said: "We are delighted David Jefferys chose this opportune moment
to reassure industry about the nature of the changes which are
afoot. We will continue to support the Department of Health in its
efforts to ensure a smooth transition from the current structure to
the new executive agency".
Dr. Jefferys was speaking at that 10th Annual ABHI Conference on
Medical Device Regulation held in London on Monday 1st July where
the Commission report on the review of the Medical Device Directive
received support from the industry. ABHI Director of Regulation
Michael Kreuzer OBE said: " We are happy that many of the
industry's concerns are incorporated into the final report. This is
an example of a how industry and regulators can work together to
achieve the best possible outcome in patient safety and market
access".
Indeed, the Medical Devices Directive review has highlighted some
shortcomings in the systems. Notified Body speaker, Alan Kirwilliam
from AMTAC criticised the lack of participation of Regulatory
Bodies worldwide in achieving effective global trade. He called the
lack of buy-in an "effective barrier to trade", and said
"...government departments worldwide are not doing enough to
implement plans for global trade. In the USA, the FDA have recently
conceded that they do not have the resource to provide follow up
training as required by their end of the deal - a joint audit. As a
result the industry is wholly dependent upon a few trained
individuals staying in their current employment"
Notes for editors: * The Association of British Healthcare Industries (ABHI) is the lead trade association for the medical systems industry. This sector comprises not only manufacturers of medical devices, equipment and consumables, but also service companies, distributors, professional groups (such as regulatory consultants and lawyers), and other suppliers to the medical community.
* The ABHI represents approx. 200 member companies with a total domestic turnover of about £3 billion representing approx. 80% of the industry output.
* The membership currently includes several Special Interest Sections and four sectoral trade associations, which in turn have a further 400 member companies.
* Member list: www.abhi.org.uk
* The role of the Association is to:
- Advance and promote medical systems (devices, equipment, technologies and services) within the UK and globally.
- Provide a forum for policy discussion with the industry's customers, legislators, public bodies and interested groups.
For further information contact:
Daniel Jones: 020 7960 4360
Email: daniel.jones@abhi.org.uk
back to previous