Impact of the MDR on the repair service of dental instruments.
- What is MDR?
The MDR (Medical Device Regulation, EU Regulation 2017/745) replaced the Medical Devices Act (or the Medical Device Directive – MDD) on 25 May 2021. The revision of the MDD was triggered by a medical device scandal that made headlines worldwide: a manufacturer had used materials for breast implants that were not approved for use in medical devices, contrary to all legal requirements. As a result, numerous patients had health problems. The aim of the new legislation – the Medical Device Regulation – is to achieve greater patient safety. It should not be transposed into national law as a directive in each country, but should be directly valid for each country as a regulation.
Since the implementation is very extensive, there is a transitional period until 26 May 2024, during which time medical devices with MDD certification can continue to be marketed and sold.
- The aim of this customer information
The aim of this customer information is to clarify the impact of the new Regulation (EU) 2017/745 (hereinafter referred to as MDR) on the repair business for dental rotary instruments.
- A description of Desos GmbH’s business activities
Desos GmbH operates a repair service within Europe for the repair of dental rotary instruments, also called straight and contra-angle handpieces, using original and non-original spare parts or standard spare parts from other manufacturers. All repaired contra-angle handpieces are subjected to a functional test according to European standards before delivery.
- What does the new MDR regulation say about the repair of dental rotary instruments (straight/contra-angle handpieces)?
- Repair of straight/contra-angle handpieces on behalf of users:
The MDR is a generally written regulation that does not explicitly address the repair of medical devices or dental rotary instruments. The definition of reprocessing according to MDR, Article 2 point 39, is most appropriate for the repair activity:
39 “Reconditioning” means a process to which a used product is subjected in order that it may be safely reused; such processes include cleaning, disinfection, sterilisation and similar procedures, as well as testing and restoring the technical and functional safety of the used product.
- Use of non-original spare parts:
Article 23 of the MDR regulates that spare parts are not to be considered as a medical device in their own right as long as they do not change or impair the performance and safety characteristics or the intended purpose of the medical device. Only when a significant change occurs is the spare part to be considered a medical device.
This also explicitly applies to the replacement of parts of a medical device with a similar spare part, i.e. any repairs that are performed using after-market, non-original parts. Desos GmbH does not alter the functionality, performance or safety of the dental instrument in any way when repairing, whether with original or with non-original spare parts.
Related to the question of repairing dental rotary instruments with original or non-original spare parts, the combination of Article 2 point 39 and Article 23, are relevant. Spare parts are not regarded as medical devices and, if it can be shown that a repair does not affect the performance of the final product, there is no impact on the legal conformity of the product. For Desos GmbH, this means that, after maintenance/reconditioning, servicing and repair, the functional features that are essential for the safety of the medical device must be tested and documented.
Furthermore, Desos GmbH only uses spare parts from manufacturers who follow all the principles of the MDR, i.e. have implemented ISO 13485 standards to ensure full production traceability.
In summary, we can confirm that you can work with Desos GmbH with the confidence that you are fully complying with the MDR.
If you have any questions or comments on this complex topic, please feel free to contact us directly.
With best regards,
Your Desos.eu Team