International regulatory seminar and workshop: NEW EU LEGISLATION EFFECT ON MEDICAL DEVICES DISTRIBUTORS’ LIABILITIES

29th & 30th November 2018
Radon Plaza Hotel Sarajevo, BIH (Croatian-Serbian-Bosnian-Montenegrian jezik)

International regulatory seminar and workshop
NEW EU LEGISLATION EFFECT ON MEDICAL DEVICES DISTRIBUTORS’ LIABILITIES

New EU regulations on medical devices will affect economic operators operating in the EU and their partners outside the EU, not only because of the harmonization of regulations, but also due to the increasing direction of EU manufacturers to deal with importers and distributors outside the EU that meet the same service standards and mutual relations as in the EU. It is therefore important to correctly understand the new requirements and their potential impact on business, and to prevent unpleasant surprises in practice. In particular, the sensitive area of new distributors’ liabilities relative to other partners should be highlighted. EU distributors are seriously accepting the advice to review existing contracts in the light of new requirements. Finding weak points often means avoiding existential problems.

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