Medical Device Classification

CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives.

The N-Pro is a Class 1 Rule 1 Medical Device and is governed by the EU’s core legal framework and complies specifically with the following Council Directive: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

N-Pro Design

Scientific Burden of Proof - Class 1 Medical Device

In order to secure medical device classification, a product needs to prove 3 scientific parameters:

  1. Safety (S): That the product is safe for the user and other players.
  2. Usability (U): That the product can be easily used and is fit for purpose
  3. Effectiveness (E): That the product works. It’s effective in carrying out its claims.
Size cm
MC: Medium Child 51cm
LC: Large Child 53cm
S: Small Adult 55cm
M: Medium Adult 57cm
L: Large Adult 59cm

Place a measuring tape around the head at eyebrow level, and measure the circumference of the head.

Choose which size is suitable for you from the table above.

If your head circumference is between sizes, select the smaller size.

UK

€5 Single product
Free shipping on two products or more
UK delivery 48hrs

Ireland

€7.50 Single product
Free shipping on two products or more
Ireland delivery 3-5 working days

Australia and New Zealand

€15 Single product
€22.50 Two products
€33.50 Three products +
Please get in touch with larger orders for optimum shipping rates
Tracked delivery 5-7 working days