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Consultation: Revision of the Medical Devices Directive and the In Vitro Diagnostic Devices
26 October 2012
The EU is proposing updated regulations
on medical devices – from home-use items like sticking plasters, pregnancy
tests and contact lenses to x-ray machines, pacemakers, breast implants, hip
replacements and HIV blood tests. The aim is to ensure these products are safe,
and can be freely and fairly traded throughout the EU.
Existing EU rules – dating back to the
1990s – have not kept pace with the enormous technological and scientific
progress in the past 20 years. Moreover different EU countries interpret and
implement the current rules in different ways.
KEY POINTS
PROPOSED FOR REVISION
The main changes being proposed at this
stage are:
- It is not always possible to trace medical devices back
to their supplier and therefore new rules on traceability are
introduced – including provision of unique device identification (UDI).
- Wider, clearer scope for EU legislation on medical
devices – extended to include, for example, implants for aesthetic purposes,
and clarified as regards genetic tests
- Stronger supervision of independent assessment bodies
by national authorities
- More powers for assessment bodies to ensure thorough
testing and regular checks on manufacturers, including unannounced factory
inspections
- Clearer rights & responsibilities for
manufacturers, importers and distributors, which would also apply to diagnostic
services and internet sales
- Extended Eudamed database on medical devices – will
provide comprehensive information on products available
on the EU market. Non-confidential data will be publicly available
- Better traceability of medical devices throughout the
supply chain – enabling a swift and effective response to safety problems (e.g.
recalls)
- Stricter requirements for clinical evidence to support
assessments of medical devices
- Updated classification rules – dividing medical devices
into 4 different risk categories and health & safety requirements,
including labelling rules – to keep pace with technological and scientific
progress
- Better coordination between national surveillance
authorities, with the Commission providing scientific, technical and logistic
support
- International guidelines to be incorporated into EU
law.
WHO WILL BE
AFFECTED?
Manufacturers, Authorised
Representatives, Importers, Distributors and Users of medical devices.
WHAT PRODUCTS
WILL BE AFFECTED?
The following products fall under the
scope of the regulations:
- Medical Devices – please refer to the text of the
relevant draft;
- In Vitro Diagnostic Devices – please refer to the text
of the relevant draft;
DEADLINE FOR
FEEDBACK
Feedback or requests for clarifications
must be sent on by 30th November 2012.
