Peter Natt and Garth Rolls-Willson present the steps a manufacturer of sports mouthguards needs to take to comply with the current PPE legislation.
Dental practitioners are sometimes asked by their patients to prescribe a sports mouthguard. One that will protect their teeth from a sudden impact while participating in sports.
However, when prescribing a sports mouthguard, dental practitioners need to carefully consider the current legislation that governs them.
The legislation that covers sports mouthguards is the PPE Legislation, be they ‘custom made’, ‘boil and bite’ ‘ready-made’ etc.
The PPE legislation is a completely separate piece of legislation. It should not be confused with the Medical Devices Directive.
What is PPE?
PPE is a number of products that the user can wear or hold. It will protect them against hazards either at home, at work or while engaging in leisure activities.
The PPE Legislation
The 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 It was superseded on the 21 April 2018, by Regulation (EU) 2016/425 on PPE. This replaced the old PPE Directive 89/686/EEC.
Categories of the PPE Legislation
The PPE Legislation allows for three categories:
- One – simple
- Two – neither simple nor complex
- Three – complex.
Which category are sports mouthguards in?
The exhaustive list of category one 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 three PPE either. They can only be covered by the main category two classification. This 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.
Any person or organisation that claims that sports mouthguards are category one is incorrect. They are providing others with false, misleading and inaccurate information.
Independent European notified bodies
Independent European notified bodies provide EEC Certification to show that the manufacturer’s products have complied to the PPE Legislation so that manufacturers may put their CE mark on its sports mouthguard.
Therefore, an independent European notified body can help sports mouthguard manufacturers find their way through conformity, declaration, certification and CE marking and support them with prototype testing.
A manufacturer of sports mouthguards can select an independent European notified body freely. It isn’t restricted to independent European notified bodies in their own country.
An independent European notified body will ensure its own test covers all of the essential requirements of the PPE legislation in the absence of a British standards test for the testing of sports mouthguards.
Dental labs and dental surgeries
If a dental laboratory or a dental surgery makes or supplies a sports mouthguard then they must comply with the PPE legislation.
There are a number of steps that manufacturers of sports mouthguards must take to comply with the PPE legislation:
- A technical data file must be created and must be available for inspection at the manufacturing site at all times
- A prototype of each of the sports mouthguards they intend placing on the market must be type tested. The technical data file must be validated by an independent European notified body. This also includes the instructions, packaging and labelling that will be sent out with the mouthguard
- An information leaflet must be supplied with the sports mouthguard. It must include the details of the name and address of the independent European notified body. Also, the certificate number, the Certificate of Conformity, and the standards used in the requirements and test methods and the date that the product was certified
- The mouthguard and/or packaging must be labelled with the CE mark in its recognisable size and form.
Please be aware that the actual prototype of the sports mouthguard is tested by the independent notified body.
CE marking
There appears to be a misconception and urban myth that manufacturers can simply use CE-marked materials and then apply the CE mark to a sports mouthguard or its packaging and that this is all one has to do to comply with PPE legislation.
This most certainly is not the case and by doing so is an illegal act and the manufacturer or supplier could be fined or imprisoned.
A manufacturer of sports mouthguards can only place the CE mark on to the sports mouthguard and/or packaging if a prototype of the of the sports mouthguard has been tested and certified by an independent European notified body.
Type testing of the sports mouthguard by an independent European notified body
The tests carried out on the prototype sports mouthguard may include an impact test. Also, a minimum thickness test in a number of different places, a delamination test, a fluid absorption test, an innoxious test, ergonomic test and a retention test.
In addition, the materials that the sports mouthguard are made from will also be tested. This ensures that they and any colouring agents used to colour them are safe for use within the oral cavity.
The container that is supplied with the sports mouthguard will also be tested, as will the user leaflet containing instructions and warnings. The name of the manufacturer must be placed on the packaging so the manufacturer can be identified.
Once the manufacturer of a sports mouthguard has had the prototype of their sports mouthguard tested, they must not change the materials or technique used to make them as this can affect the performance characteristics of the mouthguard.
If they do make any changes then they must contact an independent European notified body and ask for a re-test.
Litigation
We live in an age when consumers are only too aware that they can instigate legal action against suppliers and manufacturers of goods they believe have not come up to expectations.
Defending oneself against court action brought against you by an infuriated parent whose vast financial investment in their child’s orthodontic treatment has been lost by one blow to the mouth while wearing a sports mouthguard, manufactured by someone who was not complying with the PPE legislation, could cost the manufacturer or supplier thousands of pounds in legal fees to try to defend. This is not to mention the inconvenience, disruption and loss of reputation to their business.
Prescribers and suppliers of sports mouthguards
Anyone prescribing a sports mouthguard should take the precaution of checking that the sports mouthguards they are prescribing have been made by a manufacturer who can demonstrate that they are complying with the PPE legislation.
Ask them to provide a copy of the test certificate and certification documentation from the independent European notified body, rather than relying on the CE mark that has been placed on the packaging.
Unfortunately, a number of manufactures have simply been applying the CE mark to their products, despite them not having their sports mouthguards tested by an independent European notified body.
The danger being that if a prescriber was found to have supplied a non-compliant sports mouthguard then not only may they find themselves being prosecuted by the trading officers but if they are registered with the General Dental Council (GDC) then they are also a ‘notified professional’, which means that they may also find themselves being investigated by the GDC.
How to comply with the PPE legislation at this moment in time
At the present moment in time and in the absence of a British standard for the testing of sports mouthguards, independent European notified bodies can certify to their own test methods that satisfy the requirements of the PPE Legislation.
The manufacturer of the sports mouthguard will need to appoint a consultant to write its technical data file and, once this has been completed, get a prototype of each type of sports mouthguards it intends placing on the market tested by an independent European notified body.
The technical file consultant will be able recommend an independent European notified body. One who can carry out the type testing and provide the certification of the prototype sports mouthguard.
Each independent European notified body will have their own test in the absence of a British standard test for the testing of sports mouthguards.
The independent European notified body may send a standard test model to the manufacturer to manufacture the prototype mouthguard on.
Manufacturer with multiple manufacturing sites
Some manufacturers of sports mouthguards have multiple manufacturing sites. Each site will have to comply with the PPE legislation in its own right. They must supply a prototype for testing and certification for that site.
Brexit
The EU PPE regulation was already enshrined in UK law with effect from 21 April 2018. This was before the conclusion of the Brexit process. Now the United Kingdom has left the European Union, there is still a system for testing and certifying sports mouthguards across all 27-member states plus the UK. This will involve products carrying the CE mark, the UKCA mark, or both.
The CE mark will remain valid for the United Kingdom for two years since leaving Europe.
Test reports from ISO 17025 accredited testing laboratories should still be accepted by the independent European notifying bodies in support of UK CA applications.
The British Standards Institute (BSI) intends to remain a member of the European Committee for Standardisation (CEN). This is to continue to contribute to the development of European standards. European standards (EN) are expected to continue to be published as British standards. Although, whether this will be as BS EN XXXX or just BS XXXX has not as yet be clarified.
Certification
For sport mouthguards already certified by an independent European notified body, they will be able to continue to be sold within the United Kingdom or abroad. However, when sold within the United Kingdom the product will be CA marked rather than CE marked.
If a sports mouthguard has not been certified, is placed on the market, and is to be sold within the United Kingdom only it will need to be tested and certified by an independent European notified body. Once certified, the manufacturer must affix a CA mark followed by a specific number to the packaging and instructions.
If the sports mouthguard has not yet been certified and is to be placed on the European market then it will need to be tested and certified by an independent European notified body. When certified, the manufacturer must affix a CE mark followed by a specific number to the packaging and instructions.
Enforcement of the PPE legislation and trading standards
In the UK, the PPE (enforcement) Regulation 2018 (SI 2018/390) provides an enforcement and penalty regime for Regulation (EU) 2016/425
The PPE Legislation is enforced by Trading Standards officers. Anyone found manufacturing PPE that is not compliant with the legislation can face a fine or imprisonment. They will also have any stock confiscated.
The PPE legislation has been in existence since June 1995. Anyone who prescribes, supplies or manufactures a sports mouthguard should be complying. Ignorance of the law is no defence.
Development of a British standard for the testing of sports mouthguards
It is the long-term intention to develop a British standard for the testing of sports mouthguards. Then, independent European notifying bodies can all test to the same British standard.
However, until this has been developed, independent European notifying bodies can develop their own tests. Although, this is only possible if they fulfil the requirements of the PPE legislation.
A British standard for sports mouthguards would also ensure a level playing field. Also, a competitive element between the different independent European notified bodies.
This article first appeared in Oral Health magazine. You can read the latest issue here.
