Germany Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-23-2011, 17:27 PM

General Market Condition: No Restrictions, but CE Mark is Required
Are there special restrictions or tariffs that apply to used medical equipment but do not apply to new medical equipment?
No restrictions, but CE mark required.
If a manufacturer or its agent has registered a medical device in the country, can a third part legally import the same device in used/refurbished condition without the used device being subject to new safety inspections, etc.
According to two firms that handle used medical equipment in the German market, a used device is subject to new CE marking and conformity assessment, etc., if it is going to a new end-user. Only in cases where the end-user is exactly the same can a medical product be refurbished without new certification procedures. Thus, both firms are strict service providers, that is, they take medical equipment from their clients, refurbish it and hand it back to the very same clients; they do not sell to third parties. Even when equipment is returned to the same client, there are strict regulations governing the refurbishment, ie, not more than 50 percent of the product should be modified otherwise it is regarded as a new product and the refurbisher as a manufacturer.
Can public health institutions buy used or refurbished medical devices?
Yes, hospitals can buy used/refurbished equipment but are rather reluctant to do so; they prefer to buy state-of-the-art, new products.
Is there a market for used or refurbished medical devices?
The German market for refurbished equipment is rather limited. Still, there are a number of brokers/trading companies with worldwide activities that may be interested in working with US exporters.
There are no restrictions on the import of used equipment into Germany. New and used equipment fall under the same custom tariff categories (category number: 9018), and the same safety standards apply for both used and new products. In particular, CE marking is required for marketing both new and used medical equipment in Germany.
Traditionally, there has hardly been any market potential for refurbished equipment in Germany because of the existing strict medical product laws and because German buyers have a strong preference for new products. Recently however, and as a result of strong cost-containment pressures following the Health Reform Laws, industrial and commercial customers have positively responded to the refurbishing of medical products. At a conference organized by the German subsidiary of a US provider of refurbished medical equipment, the German medical industry concurred in principle on the advantages of refurbished equipment, provided the highest quality control standards are applied.
There was a consensus that the field of invasive cardiology was particularly suitable for refurbishment. While Class I medical products such as heart catheters and pacemakers, are subject to extremely stringent quality requirements and can only be refurbished by specialist firms in the context of a Quality Management system according to DIN EN ISO 9001 and DIN EN 46001, Class II and III products such as suction tubes and oxygen masks, can be refurbished in hospitals in a fully automated process. The German medical industry, under great cost-containment pressures, has realized that refurbished medical equipment can result in great procurement cost savings. Thus a five-time refurbishment of 2,920 gastro gavage syringes saves a German hospital approx. $ 13,666 on average and reduces the hospital's waste disposal volume by 567 kilograms. Thus, the German market for refurbished equipment is actually growing. US suppliers have to ensure, however, that a specific medical device has been refurbished according to standards outlined in the revised German Medical Products Law (' Medizinproduktegesetz-MPG ;' 2nd revision in effect as of January 1, 2002) and its respective Medical Products Operations Ordinance (' Medizinproduktebetreiberverordnung '). These tighten controls compared to the Medical Products Operations Ordinance of June 1998, in view of consumer protection and the current lobbying of industry associations against the refurbishing of so-called medical 'disposables.' The German government is promoting refurbishing for cost-containment purposes and has tightened controls, as per the revised ordinance, on some of the loopholes contained in the previous regulations. Revisions include, amongst others:

A change in definition of 'bringing to market' (cf. Para 3, no. 11 MPG);
A revised definition of 'refurbishing' in Para 3, no. 14 MPG;
A regular conformity assessment applying to those who do not return refurbished equipment to the previous user but sell it to third parties (Para 10, section 3 MPG);
Mandatory registration with the respective authorities (Health Ministry and BfArM) when refurbishing for third parties;
Inclusion of external service providers in the quality control process (Para 26, section 1 MPG); and
Amendments to the authorization for refurbishing/maintenance (Para 37; section 5 MPG).

Requirements for the refurbishing of medical products under the Medical Products Operations Ordinance are listed in Para 4, section 2 MPG, mentioning appropriate procedures and the security and health of patients, users, or third parties as top priority. Requirements include:

Validated Refurbishing.
Validated Packaging.
Validated Sterilization Procedures.
Refurbishing according to the RKI guideline. Recommendations of the Workgroup for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI), Berlin, formed the basis of the revised law. The so-called RKI guideline is available on the institute's website at RKI Startseite and has been published in the German Federal Health Register.
Liability for the health and functional safety of the refurbished products (ie, the refurbisher takes on the product liability from the manufacturer).
Quality management system according to DIN EN ISO 9001 and DIN EN 46001.

Refurbished medical products do not need a new CE certification in cases where the user outsources refurbishing and a special documentation safeguards that the refurbished products are returned to the user, ie, that there is no change in ownership.
Refurbishing of medical products focuses on the following sectors: Electro-physiology; heart surgery; endoscopy; ophthalmic surgery; neurology; urology; heart catheters; digital imaging/angiography; anesthesia; intensive care; general surgery. Excluded from refurbishing are, for example, pressure gauge syringes; spiral lead wires; teflon-coated lead wires; locks and conductors; Olbert-PTA catheters; Wilson-Cook, Endo-Flex and Dispomedica-brand endoscopy balloon catheters; lithotomy baskets; ultrasound catheters, Endo units such as clip applicators; spreaders; Endo shears; plastic implants.
The largest companies in the German refurbished medical equipment market are Remed and Vanguard. Market leader Remed of Friedeburg has approx. 250 customers, mainly hospitals, universities and individual practices, under contract and according to their press spokesperson, expects strong growth over the next few years. Even though currently, roughly 30 percent of the German hospitals refurbish their medical equipment in-house, Remed expects an increase in outsourcing as a less expensive alternative. Remed has refurbished over 250,000 medical products and over 1,000 different medical product categories over the past years. Remed maintains a website at remed - Splashseite.
US subsidiary and Berlin-based Vanguard GmbH Medical Services has successfully refurbished medical equipment in Germany since 1998 and now counts over 100 hospitals as clients. According to their chairman Robert Schroedel, the validated refurbishing can result in substantive economies of scale and savings, estimated at more than 500,000 million Euro annually for all of Europe, several million Euro for large hospitals or university clinics in Germany and 45,000 Euro annually for smaller offices and medical institutions. Vanguard Germany is currently refurbishing over 400 different medical products in validated procedures. See also their website at VANGUARD - Leading to Technological Excellence - Home.
Participation in German trade fairs is one of the most cost-effective ways of testing the market's receptivity to a product, investigating competitors and of finding customers or potential agents and distributors. German trade fairs, due to their international significance and large attendance numbers, provide an excellent vehicle for introducing new technologies and products and present a gateway to both the markets of the EU and eastern Europe. Unlike most North American trade shows, the typical German fair is much larger, represents virtually the entire industry, and is a highly successful sales point. German trade shows attract heavy attention from worldwide buyers. The following German trade show is establishing its reputation as the major European trade show for refurbished equipment. It is international in scope, giving visitors, buyers and exhibitors alike the foundation needed to start business relations.

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