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CE marking made simple.
PolarSeal is fully accredited and audited by the FDA and by European Notified Bodies, which means it can CE mark and manufacture all classes of medical devices.
CE marking a medical device is complex as there are multiple criteria to be considered when accurately classifying it, including:
Our CE marking process, at a glance
Selecting an appropriate route to conformity assessment
The 2 main medical devices and their associated regulations are:
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.
For the purposes of these regulations, an in vitro diagnostic medical device is considered to be ‘any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.
Our in-depth understanding of the MDR and IVDR means we can quickly assess which conformity assessment route applies to your device.
Device classification partially determines the conformity assessment route that needs to be taken.
The device classification process – Our extensive experience allows us to quickly classify your device
The MDR and IVDR classifies products based on their nature.
A medical device may be classified as:
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.
To find out how we can help you with your CE marking requirements, contact us today.