Focus on new Directives: TÜV SÜD at Medical 2010

Duesseldorf/Munich. When the international trade fair Medica opens on 17 November 2010 in Duesseldorf, Directive 2007/47/EC will have been in force for 241 days. At Medica, the TÜV SÜD experts will inform the manufacturers of medical devices of specific changes to be noted as a result of the Directive. Further themes at the TÜV SÜD stand in Hall 10, Stand B05: Risk management now extended to the biocompatibility of medical devices, "advanced therapy medicinal products" in practical use, and tissue engineering. The TÜV SÜD experts also offer comprehensive assistance with quality management in the health sector and a host of courses and seminars for specialist further training.

When the experts for medical devices and equipment convene at the Medica trade fair in Duesseldorf between 17 and 20 November 2010, they will have had eight months of experience with the new Directive 2007/47/EC. The Directive significantly amends the earlier Directives 90/385/EEC (relating to active implantable medical devices) and 93/42/EEC (relating to medical devices) and establishes a new legal framework for the placing of these devices on the EU market.

Interfaces with the European Machinery Directive

"The way to CE marking is paved with details. The new Directive has established new classification rules and more comprehensive requirements for technical documentation", explains Hans-Heiner Junker, TÜV SÜD Product Service GmbH. Some medical devices are also affected by the European machinery directive (2006/42/EC) and the European Directive on personal protective equipment (89/686/EEC). TÜV SÜD's medical devices experts are thoroughly familiar with the new requirements and assist manufacturers in gaining or updating their market approval for the European Union as quickly as possible.

Before medical devices receive market approval, the experts must verify their biological compatibility as per EN ISO 10993 et seq.. Important keywords in this context are 'zytotoxic', 'genotoxic' and 'carcinogenic'.

The objective of biological evaluation is to verify that the materials integrated in a medical device are safe to use in the human body. Biological evaluation is not restricted to the finished product, but includes all starting materials used either on their own or combined with other materials in the production of medical devices, as well as the conditions of production, auxiliary materials, process additives, production residues or reaction products. The requirements of the EN ISO 10993 series of standards are binding for the approval of implantable medical devices such as stents or cardiac valves, and also all other medical devices including catheters, dressings or sphygmomanometer cuffs. For the first time, the current revision of part 1 of the above series of standards now requires that biological evaluation and testing be linked with the risk management process as per EN ISO 14791. What does this mean in practice, and how can risk management be integrated effectively and efficiently? TÜV SÜD's experts give answers to this question.

Clear rules for combined advanced therapy medicinal products

Further pressing issues which TÜV SÜD addresses at this year's Medica include: How must "Advanced Therapy Medicinal Products" (ATMP) be handled in everyday practice? How exactly are medical devices placed on the EU market? From gene therapy medicinal products and somatic cell therapy medicinal products to tissue-engineered products, EC Regulation 1394/2007, which came into effect in January 2009, established clear rules for the manufacture of ATMP and "combined advanced therapy medicinal products" with permanently integrated medical devices. The handling of ATMP in everyday practice, by contrast, is still the subject of heated debate – TÜV SÜD also has the latest information on this topic.

International market approval of medical devices

Approximately half of all visitors at this year's Medica trade fair will come from abroad. On the market for medical devices and equipment, the trend towards internationalization continues unabated. The experts at TÜV SÜD Product Service support manufacturers in entering all global markets and are familiar with the entire range of approvals, be it for the Australian, Brazilian, Chinese or Saudi Arabian markets. On Thursday, 18 November from 3 pm, TÜV SÜD expert Norbert Stuiber will speak on the subject of current medical devices legislation in Saudi Arabia. The talk will take place in the lounge of the TÜV SÜD stand at the Medica trade fair.

Other focal themes at the TÜV SÜD stand: the latest developments in tissue engineering, quality management services provided by TÜV SÜD Management Service and the specialist seminar programme of TÜV SÜD Akademie.