Medical Device Regulation
What dentists need to know when it comes to maintenance and repair of medical devices
Dental Excellence: KaVo instruments and treatment units are manufactured at the main site in Biberach, Southern Germany.
Although the new regulation 2017/745 of the European parliament and the council of April 5th, 2017 for medical devices was postponed due to the Corona-Crisis until May 26th 2021, it is still coming. So what does this mean for operators of medical devices, and especially dentists? In the following text, KaVo (Biberach) will outline in detail what dentists need to know to be on the safe side of these new regulations.
The Medical Device Regulation, or MDR, refers to medical devices. This includes dental instruments and small appliances. The MDR has general validity and immediate effectiveness in all European member states, so it is mandatory within the EU.
The new regulation has been in force since 5th April 2017 but is still in a transitional phase. During this phase all those effected by the new regulation have time to implement the new regulations: The transitional phase will end with the 26th May 2021. From this day on the new EU-regulation will become fully effective.
CE-labelling
The introduction of a modified product into the market where there is a justified suspicion that it endangers the safety and health of the patients or users is prohibited according to MPG Section 4 Paragraph 1 No. 1, and therefore requires a separate conformity test.
An example: The use of a non KaVo original part in a repair or the extension of a non KaVo original accessory on an installed base can be a product modification. This may result in the manufacturer´s CE conformity and legal safety requirements no longer being maintained.
Risks of the operator
Operation, application and maintenance of a medical device are the responsibility of the operator. Therefore, it is important to identify a protocol for these users when such products require maintenance or repair.
Warranty claims and liability in case of damage.
If the defect or fault of a medical product relevant under warranty law is based on the lack of compatibility of the non-KaVo original part with the medical product, the seller or manufacturer of the KaVo original part is no longer liable. In this case, the manufacturer of the non-KaVo original part is liable for any damage. If the manufacturer of the non-KaVo original part is not liable, liability is transferred to the operator, in this case the dentist.
Users should therefore check whether the supplier or manufacturer of the non-KaVo original part has legal product liability insurance. If the registered office of the supplier or manufacturer is located abroad, the transnational coverage of the product liability insurance should be checked.
Basic verifications
The KaVo EXPERTmatic E25 L is one of the most successful instruments with a production volume of more than 100,000 pieces.
If a non-KaVo original part is used, the operator should always ensure the compatibility of the non-KaVo original part with the KaVo product.
The operator should request and check the following verifications with the manufacturer or distributor of the non-KaVo original product:
- Is the function of the product demonstrably maintained or restored?
- Are the performance characteristics of the manufacturer demonstrably not changed?
- Are the safety characteristics of the manufacturer demonstrably not changed?
- Is the intended purpose of the manufacturer demonstrably not changed?
- Is the traceability of the product demonstrably guaranteed regarding UDI (Unique Device Identification) ensured?
When installing or using non-KaVo original parts, be aware of the following criteria:
- Quality, durability
- Safety including compliance with European regulations, compatibility with the Medical devices Act, compliance with CE labeling, receipt of warranty claims and liability in the event of damage.
Specialists or dealers qualified by KaVo can be recognized by the “Certified Repair Partner” seal.
So, when using non-KaVo original spare parts, check carefully who installs and sells the parts and exactly which parts are involved. Pay attention to the quality, safety and compliance with the necessary regulations, especially in case of low-cost suppliers. You should know what possible risks you are taking if you compromise on accessories or spare parts in connection with your medical devices.
You are always on the safe side when using original KaVo parts or when repairing your medical device via the KaVo original factory repair service or via KaVo-certified repair companies.
You should be aware of the potential risks if you compromise on the accessories or spare parts associated with your medical devices.
The KaVo BOX
Keep your KaVo product a KaVo product with a top quality handpiece service & repair from us:
- In-house repair at the KaVo Repair Centre
- Knowledgeable, skilled and highly trained technicians with many years‘ experience
- Maximum transparency of costs through fixed repair prices
