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THE PERSONAL PROTECTIVE EQUIPMENT (PPE) LEGISLATION AND SPORTS MOUTHGUARDS By Peter J Natt I Dr Garth Rolls-Willson There is a lot of confusion and misinformation within the Dental Laboratory Industry regarding the implications of the Personal Protective Equipment (PPE) Legislation in relation to the manufacture of Sports Mouthguards. Sports Mouthguards include all Mouthguards destined for sports use be they ‘Custom Made’, ‘Boil and Bite’ ‘Ready Made’ etc. This paper has been written so as to clarify matters. The Personal Protective Equipment Legislation is a completely separate piece of legislation to the Medical Devices Directive and should not be confused with it. Although the vast majority of Dental Laboratories are ensuring that they comply with the Medical Devices Directive the same is not true for the Personal Protective Equipment (PPE) Legislation which became law in 1995 which is now 25 years ago. What are PPE’s PPE are products that the user can wear or hold, in order to be protected against hazards either at home, at work or whilst engaging in leisure activities.
covered by the main Category 2 classification, which requires that testing and certification or a prototype of the Sports Mouthguard that they intend placing on the market is conducted by an Independent European Notified Body.
The PPE Legislation The Personal Protective Equipment (PPE) Directive 89/686/EEC became European Law in June 1995.
Any person or organisation that claims that Sports Mouthguards are Category 1 is incorrect and is providing others with false, misleading and inaccurate information.
It was superseded on the 21st April 2018, by Regulation (EU) 2016/425 on Personal Protective Equipment (PPE) which replaced the old Personal Protective Equipment (PPE) Directive 89/686/EEC. Categories of the PPE Legislation The PPE Legislation allows for three categories being: Category 1 Simple Category 2 Neither Simple nor Complex Category 3 Complex
Which category are sports mouthguards in? The exhaustive list of Category 1 PPE in the Regulation does not include Sports Mouthguards. They are therefore not covered by this categorisation. Sports Mouthguards do not fulfil the criteria for Category 3 PPE either, so they can only be
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Independent European notifying bodies Independent European Notifying Bodies provide EEC Certification to show that the manufacturer’s products has complied to the Personal Protective Equipment (PPE) Legislation so that manufacturers may put their CE mark on its Sports Mouthguard. Therefore an Independent European Notifying Body can help Sports Mouthguard manufacturers
