Sports mouthguards are covered by the PPE Legislation, whether they are custom-made, 'boil and bite' or 'ready-made'.
Protective equipment consists of products that the user wears or holds to protect himself against hazards, whether that be at work, at home, or during leisure time.
The PPE Legislation, The Personal Protective Equipment (PPE) Directive 89/686/EEC became European Law in June 1995. It was superseded on the 21 April 2018, by Regulation (EU) 2016/425 on PPE.
The PPE Legislation allows for three categories:
One – simple
Two – neither simple nor complex
Three – complex
Which category is sports mouthguards in?
Sports mouthguards do not meet the requirements for either category one or three. Category two is the only classification that covers them. As such, Sports mouthguards must be tested and certified by an independent European notified body prior to being placed on the market.
For manufacturers to put their CE mark on sports mouthguards, independent European notified bodies issue EEC Certifications confirming that their products meet PPE Legislation. As such, an independent European notified body can assist manufacturers of sports mouthguards in navigating conformity, declaration, certification, and CE marking processes as well as support prototype testing.
Sports mouthguard manufacturers are free to choose an independent European-notified body. In the absence of a British standard test for testing sports mouthguards, an independent European notified body will ensure its own test covers all the essential requirements of PPE legislation.
PPE legislation requires manufacturers of sports mouthguards to take the following steps:
At all times, a technical data file must be available for inspection at the manufacturing site.
Sports mouthguard prototypes must be type tested before they are placed on the market. An independent European notified body must validate the technical data file. Also including the instructions, packaging, and labeling that will be sent with the mouthguard.
Sports mouthguards must be accompanied by an information leaflet. The name and address of the independent European notified body must be included. Also included is the certificate number, Certificate of Conformity, standards used in the requirements and test methods, and the certification date.
A CE mark in a recognisable size and form must appear on the mouthguard and/or packaging.
The independent notified body tests the prototype of the sports mouthguard.
It is believed that manufacturers can easily comply with PPE legislation by simply using CE-marked materials and applying the CE mark to a sports mouthguard or its packaging. In fact, this is not the case, and by doing so, the manufacturer or supplier could be fined or imprisoned. Manufacturers of sports mouthguards can only place the CE mark on the sports mouthguard and/or packaging if an independent European notified body has tested and certified a prototype of the sports mouthguard.
The tests carried out on the prototype sports mouthguard is likely to include an impact test, a minimum thickness test in several different places, a delamination test, a fluid absorption test, an innoxious test, an ergonomic test, and a retention test. Furthermore, the materials from which the sports mouthguard is made will also be tested. Consequently, they and any colouring agents used to colour them are safe for oral use. The container and user leaflet that come with the sports mouthguard will also be tested. Manufacturers' names must be displayed on the packaging to identify them. It is important for the manufacturer of a sports mouthguard not to change the materials or techniques used to make the mouthguard once a prototype has been tested. This can affect the performance characteristics of the mouthguard. The manufacturer must request a retest if it makes any changes.
UK law already incorporated the EU PPE regulation on 21 April 2018. It was before the Brexit process was concluded. Although the United Kingdom has left the European Union, there is still a system for testing and certifying sports mouthguards across all 27 member states. This will involve products carrying the CE mark, the UKCA mark, or both. Since the United Kingdom left Europe, the CE mark will remain valid for two years.
For UK CA applications, ISO 17025 accredited testing laboratories' reports should still be accepted by independent European notifying bodies. BSI intends to remain a member of the European Committee for Standardisation (CEN). As part of this, we will continue to contribute to the development of European standards. It is expected that European standards (EN) will continue to be published as British standards. Whether it will be BS EN XXXX or just BS XXXX has not yet been determined.
Sports mouthguards that are already certified by an independent European notified body may continue to be sold in the United Kingdom or abroad. In the United Kingdom, the product will, however, be marked CA instead of CE. If a sports mouthguard has not been certified, is placed on the market, and will be sold only within the United Kingdom, it must be tested and certified by an independent European notified body. Upon certification, packaging and instructions must display the CA mark followed by a specific number.
Game Guard Gumshields are a range of CE Approved, High-Quality Sports Gumshields, manufactured right here in the UK. CE marked and tested in accordance with BSI DD 253:2001 - which means that they meet the standard for size, fit, retention, level 2 for transmitted force (impact testing), and quality. Our gumshields protect teeth and helps reduce the risk of serious mouth and jaw injuries and are equally as effective as expensive alternatives.
In the long run, a British standard will be developed for testing sports mouthguards. This will allow independent European notifying bodies to test to the same British standard. Until this is developed, independent European notifying bodies can develop their own tests. However, this is only possible if they comply with PPE regulations.
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