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

**admin** · 07-24-2011, 23:48 PM

General Market Condition: No Restrictions, but CE Mark is Required
The United Kingdom has a growing requirement and interest for used medical equipment, across all sectors. The majority of such purchases are made by hospitals that are part of the United Kingdom's government-funded National Health Service (NHS). Such pre-owned equipment is subject to the same import duties and regulations as new devices.
The UK medical equipment market is driven by the NHS—the United Kingdom's universal, publicly funded healthcare system—which accounts for about 85 percent of total UK healthcare provision. As such, the NHS accounts for the majority of medical equipment purchases in the $3-billion UK market.
In the past, NHS purchases of used medical equipment have focused on radiology equipment such as X-ray machines and scanners. Currently, NHS demand covers all sectors: large surgical equipment, radiology equipment and other medical diagnostic equipment. Given the NHS' recent moves to improve the standard of care for cancer patients, the market for all pre-owned diagnostic medical equipment should increase.
The majority of used medical equipment procured by the NHS is purchased by individual hospital trusts, which are regional groupings of the 1,578 NHS hospitals. Contact information for these trusts can be found at www.doh.gov.uk .
The NHS also has a central purchasing organization—the NHS purchasing and supplies agency—( www.pasa.doh.gov.uk ) that influences more than half of the NHS' total spend on supplies. Although NHS hospitals are not required to purchase from this agency, over 98 percent of NHS trusts place all, most, or some of their business with the organization. Contacts at this agency report that in the past they have done little procurement of used medical equipment but have recently been approached by a US company who sells pre-owned medical equipment and was very interested in exploring similar opportunities. Senior buyers at PASA told us that they were there certainly was an important niche for pre-owned medical equipment in the UK market. The NHS purchasing and supplies agency can be reached on 44-1244-586-859.
In addition, over the next three years, the NHS will be purchasing $150-million worth of new cancer equipment—including diagnostic equipment, linear accelerators, and breast screening equipment—for over 200 hospitals. The purchases will be funded by the UK National Lottery's New Opportunities Fund (NOF), contact information for which can be found on the website www.noh.org.uk .
Private sector procurement of medical equipment is financed by the individual organization or hospital group. There are currently 229 private hospitals in the United Kingdom, and these organizations purchase very limited amounts of used equipment, if any at all. Information on the UK private healthcare sector can be found on the website www.iha.org.uk .
Any used or refurbished medical equipment sold in the UK market faces the same restrictions and regulations as new equipment. As with a new medical device, a used or refurbished medical device must obtain a CE mark that enables the product to be marketed anywhere within the EU. To obtain a CE mark, full compliance with the appropriate EU directive must be achieved. The three main EU medical devices directives are the EU Medical Devices Directive, the Active Implantable Medical Devices Directive, and the EU In-Vitro Diagnostic Medical Devices Directive (to be fully implemented in December 2005).
If a product has obtained a CE mark and is then refurbished, no re-registering is required if the product is refurbished with original equivalent parts (ie parts must meet manufacturer specifications). If significant alterations occur, previous regulatory approval could be invalidated.
Within the United Kingdom, the UK Medical Devices Agency (MDA) enforces regulations and deals with inquiries concerning compliance to the EU directives. Information about the MDA and full descriptions of the EU directives can be obtained on the Webster www.mca.gov.uk
Used or refurbished medical equipment is subject to the same import duties as new devices. The majority of medical equipment is classified into one of two categories in the Harmonized Tariff Schedule (HTS): HTS 9018 (medical, surgical, and dental instruments and apparatus) and HTS 9402 (medical, surgical, and dental furniture). New or used medical equipment classified under HTS 9018 and 9402 can be imported into the United Kingdom duty-free. A 17.5 percent value-added tax (VAT) is levied on the CIF value of the products (the value of the product, plus carriage, insurance, and freight).

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