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:
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.