Berlin/Germany. The German Medical Technology Association (BVMed) welcomed the Second Amendment to the German Medical Devices Act (MPG), passed by the parliament's upper house (Bundesrat) a few days ago, as a successfull work simplifying the law and making it much easier to comprehend. The lower house (Bundestag) had already decided unanimously on the Amendment on 8 November 2001. It will come into effect on 1 January 2002.

BVMed particularly praised the good and objective discussion with the Ministry for Health and the inclusion of the medical devices manufacturers' positions in the legislation procedures. "Innovations in accordance with the safety of patients and an optimized patient care can only be achieved by close collaboration of manufacturers, surveillance authorities and legislative bodies. The amendment of the Medical Devices Act is a prime example that this can actually work in practice", said BVMed Director General Joachim M. Schmitt. 

According to BVMed, the much stricter requirements for the reprossession of single-use medical devices are crucial for the safety of patients. The reference to the lately introduced recommendations of the Robert-Koch-Institute (RKI) on the "requirements on the hygiene in the reprocessing of medical devices" is an important step in the right direction, said BVMed. Now, the compliance with these stricter specifications would have to be monitored accordingly and - in case of non-compliance - the appropriate measures would have to be taken.

BVMed also rated the successfull deregulation in the area of "advertising for medical devices" as positive. The association expressed its satisfaction on the fact that the industry's suggestions had been adopted by the lower house. BVMed is preparing a brochure on the issue, which is planned for 2002.

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