Medical Product Law

Medical Product Law

Introduction

On 14 June 1998 - after a 5 year transition period- a new law, the law about medical products (MPL), received legal validity. Medical products are defined as equipment, (incl. software), which are meant for people for simple application. This equipment is classified in four risk categories, namely category I, Iia, Iib, III. Almost all aids of our enterprise fall into risk category I. Following the above mentioned deadline (14.06.1998) the known GS mark, which was regarded as a voluntary quality confirmation is forbidden for Medical Products.The GS mark (quality mark) isn´t used with the CE mark (conformity mark). Products of our house are also quality checked furthermore by independent institutes voluntarily, over and above the necessary measures (CE), though documented by a new (other than GS-) mark what sign must be documented (the exact detail of this sign isn´t certain yet.) Whoever produces the medical devices and puts them into circulation has to carry out the conformity method. This consists of strict conditions and comprehensive documentation. E.g. the risk analysis (which dangers come from the device?) count as one of them. E.g. an explanation about toxicity questions and much more but also exact predefined interpretation and calculation regulations according to suitable norms. Our documents regarding this for our products are at your disposal, which will make the work easier for you and limit the risk before the background of the MPG. In many cases you make, for example, artificial legs. For this personal product (custom made) you are regarded as a manufacturer and must inevitably carry out the compliance procedure on Medical Product Adviser, Safety Representative for Medical Products, and amongst others an organized registration system. When you make changes to a wheelchair, over and above the specified customization, (e.g. adjusting the length of the leg support) and make use of the unit construction system (e.g. you make a wheelchair with an individually formed seat bowl), you are regarded as a manufacturer with all the responsibility that comes with it. Because this seems to happen daily, we support you completely, on this occasion. Now to questions about the re-use of medical products, such as wheelchairs as well as other aids of our company. Whoever refurbishes medical products to the so-called original condition and sells them on, doesn’t bring the product new to circulation. With "original condition", what is meant here is the first delivery status into trade, this being the condition at the transfer of ownership of the manufacturer to the dealer. Because therefore, there are no new products going into circulation, no compliance procedure needs to be carried out (example: Exchange of the weheelchair billets for new original billets). The difference is when medical products are refurbished to conditions other than the original condition. This is often the case when products are brought to a new level of technology, e.g. if an electrical wheelchair receives a control of an improved generation. This measure leads to a condition, which differs from the original condition and legally meant it is put anew into circulation. The compliance procedure must be carried out (here MEYRA instrumental.) From these basic considerations it can be derived that the one who repairs medical products and doesn’t use spare parts/attachment parts released by the manufacturer and/or doesn’t work according to the regulations of the manufacturer brings them anew into circulation.

What does the CE sign mean?

The requirements on a medical device are determined in the EC-guideline 93/42 EEC from14-6-1993. This so-called "Medical Devices Directive" (MDD) was implemented in the mean time as Medical Product Law (MPL) in national German law. The conformity is clear on the product by a CE sign. This CE sign isn´t a quality mark; it generally shows that the product on hand is compliant with a harmonized European guideline. It has to be indicated in the documentation enclosed with the product and with MEYRA products this is in the enclosed operating instructions.

What has to be taken into account with adjustments and repairs?

The specialized trade and the user can be assured that the requirements of the MPG are observed on all MEYRA medical devices with the CE-marking. The conformity is also preserved if with adjustments the original attached parts from the accompanying icon (possible equipment for the wheelchair) as well as in the case of repair MEYRA or Petri spare parts are used. The individual components of the unit assembly equipment of the aid/device in question were also checked in the combination with each other at MEYRA. The printed conformity explanation therefore also contains the code parts (equipment, accessories) of the respective model.

What has to be taken into account with custom made devices?

Special models aren´t provided with a CE-marking. They have to be indicated as a special model separately on the serial plate. At delivery the person has to document the delivery status as well as the name of the patient and the person who ordered. The company which implements this custom made devices is a manufacturer in the sense of the law.

How is the conformity guaranteed to MPG?

Central statement of the MPG is the demand that there is no danger for the user or patient in any of the medical devices. Whoever produces the medical devices and puts them into circulation has to carry out the compliance valuation procedure. This consists of strict conditions and comprehensive documentation. E.g. the risk analysis (which dangers come from the device?), an explanation about toxicity questions and much more but also exact predefined interpretation and calculation regulations according to suitable norms. If with the use conditional conceptual inevitable risks can arise, these have to be pointed out here in a suitable way. Here the operating instructions, the adhesive bonding on the wheelchair, as well as perhaps necessary advice papers, are of a special significance. The identification of the products, which is important, must be indicated by a clear frame number or batch number. This identifies the MEYRA products by the serial plate. Additionally, in particular the complex electric wheelchairs, MEYRA also indicates individual components of electronics as well as the drive.

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