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serves clients' specific needs with changes
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By: Ludger Möller

Special News and Views IV

MDSS was contacted by clients regarding the new warranty directive. This special News and Views shall outline briefly the requirements. MDSS tried as well to receive legal advice regarding this new directive but we were not able to obtain definite answers. Therefore I need to point your attention to the disclaimer provided at the end.

Directive 99/44/EC on certain aspects of the sales of consumer goods and associated guarantees

Internet Link:  

Please view the directive under the following link: http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31999L0044&model=guichett

Please view the summary under the following link:
http://europa.eu.int/scadplus/leg/en/lvb/l32022.htm

Introduction

The directive regulates the sales of consumer goods and associated guarantees and is implemented to ensure consumer protection and strengthen consumer confidence in cross-border shopping by laying down a common set of minimum warranty rules valid no matter where the goods are purchased.

The time limits:

The seller shall be held liable where the lack of conformity becomes apparent within two years as from delivery of the goods (Article 5). Furthermore it stipulates that unless proved otherwise, any lack of conformity which becomes apparent within six months of delivery of the goods shall be presumed to have existed at the time of delivery unless this presumption is incompatible with the nature of the goods or the nature of the lack of conformity.

The directive shall be implemented by the member states by January 1, 2002 (Article 11). In Germany the directive is transposed into national law and will be applied on the due date. The consumer is being made aware of the change due to the fact that certain retailers offer the change in guarantee already for the Holiday season before the due date.

Scope and Definitions

For the purpose of this memo the definitions a, b and e of Article 1 of the above mentioned are given.

(a) Consumer: shall mean any natural person who, in the contracts covered by this Directive, is acting for purposes which are not related to his trade, business or profession
(b) Consumer goods: shall mean any tangible movable item, with the exception of:
- goods sold by way of execution or otherwise by authority of law,
- water and gas where they are not put up for sale in a limited volume or set quantity,
- electricity;
(e) guarantee: shall mean any undertaking by a seller or producer to the consumer, given without extra charge, to reimburse the price paid or to replace, repair or handle consumer goods in any way if they do not meet the specifications set out in the guarantee statement or in the relevant advertising;

Applicability to medical device

The directive affects all manufacturers, importers, wholesalers, retailers of consumer goods sold to consumers in any of the European Union Member State.

It becomes apparent that the directive is not applicable to all medical devices for two reasons.

Who is the consumer? What are consumer goods?
Those terms need to be further evaluated with keeping the medical market in mind in order to determine whether the directive is applicable. For example the hospital or physician purchases and uses the product.

Another aspect applies for a number of products for example products with a limited lifetime. It becomes obvious for sterile products but other products may have a shorter lifetime than two years as well. The lifetime of the product must be clearly stipulated and the consumer must be informed about those aspects. Article 2 section 3: “There shall be deemed not to be a lack of conformity for the purposes of this Article if, at the time the contract was concluded, the consumer was aware, or could not reasonably be unaware of, the lack of conformity, or if the lack of conformity has its origin in materials supplied by the consumer”.

Summary:

Most medical devices will be excluded from this directive however the implementation of such a directive with the high level of common awareness the guarantee/warranty may be requested by all purchasers. The common interpretation of the term consumer therefore might change in this regards and manufacturers are being faced to provide extended guarantee on all products.

Disclaimer:

MDSS provides this information about the European Union regulation concerning directive 99/44/EC as an additional service. Our objective is to provide information timely and accurate. If errors are brought to our attention, we will try to correct them.

However, MDSS accepts no responsibility or liability whatsoever with regard to the material. This material is:

information of a general nature only which is not intended to address the specific circumstances of any particular individual or entity;
not necessarily comprehensive, complete, accurate or up to date;
sometimes linked to external sites over which MDSS has no control and for which MDSS assumes no responsibility;
not professional or legal advice (if you need specific advice, you should always consult a suitably qualified professional).

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