Introduction
A new law on medical devices came into force on 26 May 2021. The Medical Devices Implementation Act (MPDG) replaces the previous Medical Devices Act (MPG).
In very simplified terms, medical devices are defined as devices (including software) intended for human use. These devices are mainly classified into four risk classes, namely classes I, IIa, IIb, III. All of our company's tools fall into risk class I. Our products continue to be voluntarily tested for quality by independent institutes beyond the required level (CE). Anyone who manufactures medical devices and places them on the market must carry out the conformity procedure. This consists of strict requirements and comprehensive documentation. This includes, for example, the risk analysis (what dangers does the device pose?), e.g. a statement on toxicity issues (toxicity) and much more, but also precisely specified design and calculation regulations according to corresponding standards. For our products, our documents in this regard are available to you, which facilitate your work and limit the risk against the background of the MPDG. In many cases, you make leg prostheses, for example. For this personalised product (custom-made product), you are considered a manufacturer in all cases and must necessarily carry out the conformity procedure, have medical device advisors, MDR medical device representatives, an organised reporting system, etc. If you make modifications to a wheelchair that go beyond the intended adaptation (e.g. adjusting the length of the legrest) and the use of our modular system (e.g. you manufacture a wheelchair with an individually shaped seat shell), you are deemed to be the manufacturer with all the responsibility that can be derived from this. Since this happens every day, we support you fully in this. Now to questions of the reuse of medical devices, in this case wheelchairs as well as other aids of our hospital. Anyone who refurbishes medical devices to their so-called original condition and returns them to the market does not place them on the market anew. The term "original condition" refers to the condition of the vehicle when it was first put on the market, i.e. the condition when ownership was transferred from the manufacturer to the dealer. As this is not a new placing on the market, no conformity procedure needs to be carried out (example: Replacement of the wheelchair seat with an original seat). It is different when medical devices are refurbished to a condition other than their original state. This is often the case when products are upgraded to a new state of the art, e.g. an electric wheelchair receives a control system of an improved generation. This measure leads to a condition that deviates from the original condition and legally means placing on the market anew. The conformity procedure must be carried out (MEYRA can assist here). Based on these fundamental considerations, it can be deduced that anyone who repairs (reprocesses) medical devices and does not use spare parts/attachments approved by the manufacturer and/or does not work according to the manufacturer's instructions is placing them on the market anew.
What does the CE mark mean?
The requirements for a medical device are set out in Regulation (EU) 2017/745 of 05.04.2017. This so-called "Medical Device Regulation" (MDR) has since been transposed into national German law as the Medical Device Implementation Act (MPDG). Conformity is indicated on the product by a CE mark. This CE mark is not a quality mark; it indicates in general that the product in question is in conformity with a harmonised European directive. It must be stated in the documentation accompanying the product and, in the case of MEYRA products, can be found in the enclosed operating instructions.
What should be observed during fitting work and repairs?
With MEYRA medical devices bearing the CE mark, the specialist trade and the user can be sure that the requirements of the MPDG are met. Conformity is also maintained if the original attachment parts from the associated pictogram (the equipment options of the wheelchair) are used for fitting work and MEYRA spare parts are used in the event of repairs. The individual components from the equipment kit of the aid in question were also checked in combination with each other at MEYRA. The printed declaration of conformity therefore also includes the code parts (equipment, accessories) of the respective model.
What has to be considered for custom-made products?
Custom-made products are not provided with a CE mark. They must be marked separately on the type plate as a special design. On delivery, the manufacturer must document the state of delivery as well as the name of the patient and the prescriber. The company carrying out this special production is a manufacturer within the meaning of the law.
How is conformity with the MPDG ensured?
The core statement of the MPDG is the requirement that a medical device must not pose a risk to the user, operator or patient. Anyone who manufactures medical devices and places them on the market must carry out the conformity assessment procedure. This consists of strict requirements and comprehensive documentation. This includes, for example, the risk analysis (what are the dangers posed by the device?), a statement on toxicity issues (toxicity) and much more, but also precise specified design and calculation regulations according to corresponding standards. If, for conceptual reasons, unavoidable risks may arise during use, this must be pointed out in an appropriate manner. Here, the operating instructions, the stickers on the wheelchair and any necessary information documents are of particular importance. It is also important to identify the products, which must be marked with a unique frame or batch number. This is indicated on the nameplate of MEYRA products. Especially for the complex electric wheelchairs, MEYRA also marks individual components of the electronics and the drive.