Introduction to Medical Device CE Marking

Posted Tue, 10th December 2019

We offer the CE marking service as a quicker route to market for our client’s new developments

What is a CE mark?

A CE mark allows your medical device to be sold across Europe, hugely increasing the market accessible to you as it shows that you have checked that it meets EU safety, health or environmental requirements.

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
  • if 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.

You may be wondering if your medical device development needs CE marking at all.  At PolarSeal, we use our experience to accurately classify your device for you.

Medical Devices are classified as:

  • Class I
  • Class IIa
  • Class IIb
  • Class III

The higher the classification the greater the level of assessment required.


PolarSeal ostomy component manufacture

Why use PolarSeal?

We understand how fast the medical market moves so we know you want to get your product to market as soon as possible.  PolarSeal is dedicated to innovation.  With that in mind we want to enable entrepreneurs to unleash their potential without being side-tracked by legal necessities such as CE marking.

Once we have classified your product, we prepare the required paperwork and carry out rigorous testing, qualifying it for a CE mark.  Our manufacturing capabilities are accredited to the MDR standard and this makes us the ultimate all-in-one solution.

Richard Nowak, PolarSeal’s quality manager explains:  “With our industry-leading R&D resources and being an accredited manufacturer of all classes of medical devices, we save time and money for innovative product developers that don’t have 13485 certifications.”

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

Contact us today to find out how we can help you.

+44 (0) 1252 726000