Source: BSI - Global site
What is a CE Mark?
It is legally required to CE mark any product which comes under a European
Directive in order to market it in the European Union.
CE marking is the manufacturer's claim that the product meets the essential
requirements of all relevant European Directives. Information on European
Directives can be found through our web links page and at the British
Standards Institute (BSI) website.
CE marking requirements vary from directive to directive, and even within
directives. Third party testing, systems assessment and technical file assessments
can be a mandatory requirement, but in some cases the manufacturer's unverified
claim is all that is asked for. Bear in mind that if you claim your product
complies and it doesn't, prosecution will ensue.
There are a number of authorities which can aid you in satisfying the
requirements of applicable directives. The BSI has produced several guidance
The directives of particular relevance to the Medical Device Manufacturing
Industry are outlined below. This list is not exhaustive, so check with
the relevant bodies for further information on exactly which Directives
need to be complied with.
- Active Implantable Medical Devices
- Electrical Equipment (LVD)
- Electromagnetic Compatibility
- In Vitro Medical Devices
- Medical Devices
- Packaging and Packaging Waste
- Personal Protective Equipment
- Pressure Equipment
- Safety of Machinery.
Carrying out independent testing and assessments is the safest way for manufacturers
to proceed, whether this is mandatory or not. This enables a company to
claim a defence of due diligence, should the question arise. Where a directive
requires products and systems to be independently tested, certified, or
inspected, this must be done by a Notified Body or Competent Body, an organisation
nominated by a member Government and Notified by the European Commission.
Information on Notified bodies can be found through our web links pages.
EU Medical Devices Directive 93/42/EEC
Source of information: AMTAC Certification Services Limited
The EU Medical Devices Directive provides a single, unified approach to
regulatory compliance for all suppliers of Medical Devices to the European
To apply the EU Medical Devices directive and thereby gain the CE mark
for your product requires the following steps:
|1. || are relevant to your product |
|2. ||Identify the risk classification of your product |
|3. ||Choose your Notified Body |
|4. || with your classification |
|5. ||Explore the conformity options available to you |
|6. ||Implement applicable conformity route |
|7. || Requirements' |
|8. ||Compile and validate all appropriate documentation |
|9. ||Develop product labelling and instructions |
|10. ||Arrange for a Notified Body audit |
|11. || its packaging and accompanying literature. |
Stage 1: Identify and obtain a copy of the applicable Directive(s)
This can be obtained by visiting:
The Directive was implemented in January 1995 has been mandatory since
June 1998. It applies to all legally defined manufacturers who place on
the market a medical device or medical device accessory.
Non EU located manufacturers who wish to sell in the EU must also apply
the CE Marking to their products and may be subjected to a Notified Body
Stage 2: Device Risk Classification
Classification is concerned with the following points:
- The nature of the device (active, re-usable etc)
- How long the device will be in contact with the body
- The part of the body that the device will be in contact with
- How the device will attach to or penetrate the body
- The intended purpose for the device.
It is the manufacturer's responsibility to classify the device, but
the Notified Body must agree with this classification, validating the
evidence that the stated purpose is actually viable.
Stage 3 and 4: Choosing a Notified Body
Refer to the separate section on Notified Bodies which outlines the
services that Notified bodies provides contacts in Scotland.
Stage 5: Conformity Options
All devices, except those classified Class I, require an audit by an
appropriate Notified Body. The Directive details the available conformity
assessment procedures and offers the manufacturer a number of options
for conformity. It is a good idea to ensure that the option chosen meets
your mandatory requirements and is also beneficial from a manufacturing
perspective. Liaison with your chosen Notified Body is advised.
Stage 7: Implement your conformity route
Generally, manufacturers are advised to use the relevant Harmonised
Standard to interpret the requirements of the Directive with regard to
their EC Declaration of Conformity.
Further details are available from the Notified Body, who will advise
on implemention in conjunction with the harmonised standards. This will
additionally permit manufacturers to be registered against ISO 9000/EN
46000 as part of the audit process. The regulatory, management and marketing
requirements can be combined in one procedure. It is worth noting that
good project management of the implementation programme and incorporation
of the statutory compliance issues of the Directive is advisable.
If you have already met other external requirements (e.g. FDA) and have
existing systems designed it is often a good idea cross-reference your
compliance systems, which will aid in avoiding duplication, unnecessary
expense and system conflicts.
Stage 8: Ensure your devices comply with the 'Essential Requirements'
Demonstration that your device is both safe and achieves its intended
purpose must be made to your Notified Body, thereby satisfying Annex I of
the Directive, 'Essential Requirements'.
Independent testing is not always required. The manufacturer must demonstrate
satisfactory risk analysis and methodology.
Stage 9: Compile and validate all appropriate documentation
It is mandatory to comply with the Directive but it is also a good opportunity
to develop a sound quality management system that will benefit your organisation.
Development of internally and assessment formed documentation will save
on administration, with the use of checklists and flow charts. Details of
this can be found in appropriate ISO quality manuals.
It is recommended that an internal audit be carried out before contacting
your Notified Body for assessment. Care should be taken to ensure that all
aspects of the Directive are considered and acted upon according to your
Stage 9: Develop product labelling and instructions
Device classification is dependent upon the manufacturers intended purpose
and all aspects will be covered by your audit, including labelling and
product instructions. It is possible that other marketing material, such
as product catalogues, may be considered. The requirements for labelling
and other information to be supplied by the manufacturer are detailed
in the Directive.
Areas to consider are:
- Who the ultimate user will be
- What language the user speaks
- National requirements.
It is recommended that symbols be should be used wherever possible,
appropriate symbols can be found in EN 980:1997 'Graphical Symbols for
Use in the Labelling of Medical Devices'. These symbols should be displayed
in addition to your CE marking, as detailed in the Directive.
Stage 10: The Notified Body Audit
Approximately 4 to 8 weeks prior to the audit date you will have to
ask your Notified Body to review your quality system documentation. This
allows you some time to implement any required corrective actions.
Audit duration will typically be between three and ten days dependent
upon the size of your organisation, the number of device families involved
and their classification.
Subcontractors, control of components and critical services will be
addressed. If these subcontractors manufacture major device components,
or supply critical parts or services which could detrimentally effect
the efficacy of your device(s), then your Notified Body may need to audit
these organisations as well.
Any non-conformities found during the initial audit will given a time-line
within which appropriate corrective action can be undertaken. As soon
as all non-compliances have been satisfactorily cleared, the Notified
Body will recommend that the CE Marking and any other associated registration
(ISO 9000) be applied to your product. Regular surveillance is required
by your Notified Body, this is often carried out once or twice a year.
Once in possession of device CE marking you will have the freedom to
access the market place in all EU Member States.
New Approach Directives
The New Directives will affect the following areas of the Medical Device
|DIRECTIVE No. ||DIRECTIVE NAME ||DATE OF APPLICATION BY MEMBER |
|END OF TRANSITION PERIOD |
|73/23/EEC ||Low Voltage Equipment (LVD) ||Aug 1974 ||--- |
|89/336/EEC92/31/EEC ||Electromagnetic Compatibility (EMC) ||1 Jan 1992 ||31 Dec 1995 |
|89/392/EECREPEALED BY98/37/EC ||Machinery ||1 Jan 1993 ||31 Dec 1994 |
|90/385/EEC ||Active Implantable Medical Devices |
|1 Jan 1993 ||31 Dec 1994 |
|90/396/EEC ||Gas Appliances ||1 Jan 1992 ||31 Dec 1995 |
|93/42/EEC ||Medical Devices (MDD) ||1 Jan 1995 ||13 June 1998 |
|94/62/EC ||Packaging and Packaging Waste ||20 Dec 1994 ||1 May 1998 |
|95/79/EC ||In Vitro Diagnostic Medical Devices ||7 December 1999 ||7 December 2003 |
|98/37/EC ||Machinery ||1 Jan 1993 ||31 Dec 1994 |
The EU In-Vitro Diagnostics Directive 98/79/EC
Source of information: AMTAC
The EU In-Vitro Diagnostics Directive has been in existance since December
1999. By December 7 2003, five years after the publication of the Directive,
only CE marked devices may be placed on the market. By December 7 2005,
7 years after the publication date and the end of the implementation transition
period, only CE-marked devices wil be permitted to be put into service.
Aims of the Directive
This Directive supplements the Community's legal requirements for placing
a medical device on the EU market. It extends the legislation to include
in-vitro diagnostic medical devices.
It is broadly based on the medical device directive and the active implantable
medical device directive and ensures uniform development rules.
The Directive requires evidence of:
- The reliability of the devices
- The intended purpose of the device
- User and third party protection.
The IVD Directive generally follows the Medical Devices Directive, with
- The introduction of particular health monitoring measures
- A list of in vitro diagnostic medical devices regarded as sensitive
- Specific provisions on market surveillance
- Rules applicable to the notified bodies.