WRITTEN QUESTION E-0011/01 by Glyn Ford (PSE) to the Commission. Metrication.
Date: 2001-01-17
Institutions: European Parliament, Provisional data
Subjects: EC Directive, United Kingdom, complaint to the Commission, infringement of EU law, weights and measures

C 174 E/244

Official Journal of the European Communities

EN

19.6.2001

Answer given by Mr Liikanen on behalf of the Commission

(12 March 2001)

Whether or not medical devices can be re-used depends on the intended purpose of a device as defined by
the manufacturer on the basis of design and technical constraints. Where a manufacturer puts devices on
the market for re-use, such devices are always accompanied with instructions on the appropriate processes
to allow safe re-use, such as cleaning and re-sterilisation, and indications on the expected life of the device.
As regards devices intended for single use, manufacturers have not carried out testing which would
take
demonstrate the performance of
responsibility for re-use.

the device in circumstances of re-use and therefore cannot

The Commission is aware of the re-use of devices intended for single use, but as re-sterilisation can change
the structure of the device and impact on its performance (e.g. existence of (cid:145)sterilised dust(cid:146)), particular
precautions must be taken by the hospitals to verify if safe re-use is feasible and determine the appropriate
reprocessing of the devices. The costs of such testing and corresponding processes are considerable, and
must be taken into account in the evaluation of possible savings. Furthermore, reprocessing of (cid:145)single-use(cid:146)
medical devices falls outside the scope of the Directives on medical devices and on active implantable
medical devices.

The Commission is aware of the implications to Member States(cid:146) national budgets of the present situation.
It has no specific data on the potential costs. In meetings organised by the Commission between Member
State authorities(cid:146) experts and industry, the question of whether the intended purpose of medical devices
should be determined by technical safety-related reasons alone or also on economic considerations is being
discussed. The appropriateness of redesigning (cid:145)single use(cid:146) devices into reusable devices with well established
conditions for use, should be evaluated together with conditions of re-use of single use devices, aiming at
reducing costs while maintaining quality and safety.

(2001/C 174 E/262)

WRITTEN QUESTION E-0011/01

by Glyn Ford (PSE) to the Commission

(17 January 2001)

Subject: Metrication

EU legislation regarding the use of metric units came into force in the UK in 2000.

However, many major supermarkets in the UK have either ignored using metric weights on their labels or
display the price per pound (lb) much more prominently than the price per kg, which contradicts the
Directive(cid:146)s requirements.

What plans does the Commission have to ensure that this Directive is fully implemented in the UK?

Answer by Mr Liikanen on behalf of the Commission

(7 March 2001)

The matter to which the honourable Member refers is the subject of a complaint that has just been made
to the Commission. An investigation is currently under way with regard to the Member State involved in
order to obtain the necessary facts concerning the matter that has been reported.
If necessary, the
Commission will not hesitate to take appropriate action in accordance with the procedure laid down in
Article 226 of the Treaty.