CE Marking

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:

  • 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.

Our CE marking process, at a glance

Selecting an appropriate route to conformity assessment

The 2 main medical devices and their associated regulations are:

  1. General medical devices: The EU Regulation on Medical Devices 2017/745

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.

  1. In vitro diagnostic medical devices (IVDs): The EU Regulation on In Vitro Diagnostic Medical Devices 2017/746

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:

  • Class I (low risk) – Provided non-sterile or do not have a measuring function
  • Class I (low/medium risk) – Provided sterile and/or have a measuring function the MDR adds to this group, reusable surgical instruments as Class I reusable surgical instruments.
  • Class IIa (medium risk)
  • Class IIb – (medium/high risk)
  • Class III – (high risk)

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.

T: +44 (0)1252 726000
E: info@polarseal.net