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Audits and CGMP Audits for worldwide standards.
What are the Standards?
1. This directive shall
apply to medical devices and their accessories. For the
purposes of this directive, accessories shall be treated as
devices in their own right. Both medical devices and
accessories shall hereinafter be termed devices.
2. The devices must be designed and manufactured in
such a way that, when used under the conditions and for the
purposes intended, they will not compromise the clinical
condition of the safety of patients, or the safety and
health of users or, where applicable, other persons,
provided that any risks which may be associated with their
use constitute acceptable risks when weighed against the
benefits to the patient and are compatible with high level
of protection of health and safety.
3. The solutions adopted by the manufacturer for the
design and construction of the devices must conform to
safety principles, taking account of the generally
acknowledged state of the art.
In selecting the most
appropriate solutions, the manufacturer must apply the
following principles
in the following order:
+ eliminate or reduce risk as
far as possible (inherently safe design and construction),
+ where appropriate take
adequate protection measures including alarms if necessary,
in relation to risk that cannot be eliminated,
+ inform users of the residual
risk due to any shortcomings of the protection measures
adopted.
4. The devices must achieve the performances intended
by manufacturer and be designed, manufactured and packaged
in such a way that they are suitable for one or more of the
functions referred to in Article 1(2) (a), as specified by
the manufacturer.
5. The characteristics and performances referred to
in Sections 1, 2 and 3 must not be adversely affected to
such a degree that the clinical conditions and safety of the
patients and, where applicable, of other persons are
compromised during the lifetime of the device as indicated
by the manufacturer, when the device is subjected to the
stresses which can occur during normal conditions of use.
6. The devices must be designed, manufactured and
packed in such a way that their characteristics and
performance during their intended use will not be adversely
affected during transport and storage taking account of the
instructions and information provided
by the manufacturer.
7. Any undesirable side effect must constitute an
acceptable risk when weighed against the performance
intended.
Source:
Council Directive 93/42/EEC
|
Regulatory Models (Global
Harmonization Task Force (GHTF) members) |
| |
US |
Australia |
Japan |
EU |
Canada |
|
Regulatory Body |
Food & Drug Administration (FDA) |
Therapeutic Goods Administration (TGA) |
Ministry of Heath and Welfare (MHW) |
Competent Authority (CA) ( 15 states
) |
Health Canada (HC) |
|
QS standard |
QSR: 21 CFR
820 |
ISO 13485/8 or EN 46001/2 |
QS standard 1128 |
EN 46001/2/3 |
ISO 13485/8 |
|
Quality Systems auditor |
FDA |
TGA |
MHW |
Notified Body (NB) (3rd
party) |
Registrar (3rd party) (CMDCAS) |
|
Pre-market reviewer |
FDA |
TGA |
MHW |
(NB) (3rd party) |
HC |
|
Post-market compliance & enforcement |
FDA |
TGA |
MHW |
(NB) (3rd party) + CA |
HC (6 Regions) |
