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certification

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Certifying medical devices

PolarSeal is registered and audited by the FDA and by a European Notified Body. PolarSeal is accredited to CE mark and manufacture our EctoCare range of products which are classified IIb. which means it can CE mark and manufacture classes up to IIb for our EctoCare range of products.

CE marking medical devices is complex as there are multiple criteria to be considered when accurately classifying it, including:

  • how long the device is intended to be in continuous use
  • whether or not the device is invasive or surgically invasive
  • whether the device is implantable or active
  • whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
Product certification
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Selecting an appropriate route to conformity assessment

General medical devices: The EU Regulation on Medical Devices 93/42/EEC.

 

In this context, a medical device is defined as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.

The preparation of your technical file

After the classification process is complete, we undertake a rigorous series of tests on your device and comparisons to similar products on the market. The complexity of this testing phase increases in-line with the classification of your product.

 

The results of our testing and other procedures are collated and presented to a Notified Body as a technical file, which is used to qualify the device as a ready-to-sell CE marked product.

 

In summary, PolarSeal makes the whole process easier and propels your product to market.

The impact of BREXIT

The ways in which medical devices manufactured for sale in the UK are regulated may well change as a result of the final BREXIT outcome. We are prepared for all eventualities and remain dedicated to providing you a smooth service.

Get in touch to discuss your project requirements in more detail

Send us an email to discuss your project requirements in more detail or book a 1-on-1 video call with a member of the team on a day and time that suits you best using the calendar booking system.

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