| Before you can sell a medical device or IVD within
Europe, you must place a CE Mark (CE Marking) on your
product. The CE Mark is not a quality certification nor
is it intended for consumers. It is used by the European
Competent Authorities (National Ministries of Health) as
a way to quickly determine whether your product has met
all of the requirements of the Medical Device Directive
93/42/EEC, In Vitro Diagnostic Directive 98/79/EC or the
Active Implantable Medical Device Directive 90/385/EEC.
The Medical Device Directive states that companies
must: -
- Compile a Technical File with evidence of compliance to
the Medical Device Directive (or the IVD/AIMD
Directives)
- Receive a CE Mark (CE Marking) certificate from a
Notified Body if medium or high risk device
- Appoint an Authorized Representative if you have no
physical location in Europe
- Register their medical devices with the Competent
Authorities
Only after these requirements are satisfied are allowed
to place the CE Mark on your device.
Prinsip Mahir has helped medical device companies
with CE compliance. Our services include: -
- Technical file compilation and review
- Verification of Essential Requirements
- Product classification and identification of applicable
CE Marking standards
- Implementation and maintenance of ISO 13485 quality
systems
- Product labeling and packaging review
- Risk assessment and management (ISO 14971)
- Development of Vigilance Procedures and Post Market
Surveillance
- Authorized Representation for Europe
Our quality systems meet European, US, Canadian and
Australian requirements for device exportation to
oversea
If you currently have no quality system in place, we
will develop and implement an ISO 13485 system on a fast
track to get your company certified to sell and ship
into Europe. Each system is customized for the
manufacturer and will not only ensure compliance to the
European Directives for Medical Devices (CE Marking),
but also to the Canadian Medical Devices Regulations,
United States FDA QSR and Australian TGA requirements at
no additional cost!.
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