Medical Device Law Transitional period ends soon, with EN 60601-1 3rd ed. taking effect
On June 1, the third edition of the international standard EN 60601-1 replaces the second for electrical medical devices to which no specific device standard applies, the BSI Group warns. For all other electrical medical devices, the transitional period ends once the associated revised device standard has been harmonised.
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The coming change will have a far-reaching impact on the distribution of electrical medical devices covered by no specific device standard if manufacturers have tested those devices only according to the EN 60601-1, 2nd ed., by the time June 1 arrives. The devices will no longer be deemed compliant with reference to the fundamental requirements of the Medical Devices Directive covered by EN 60601-1.
In order to adapt their devices to the requirements of the third edition of EN 60601-1, manufacturers must implement a risk management process according to EN ISO 14971 to supplement the standard’s requirements, and must conduct corresponding examinations. Existing risk management files must be adapted to the requirements of the 3rd edition of EN 60601-1.
“Timely adaptation of devices, including the required processes, to the third edition of EN 60601-1 will create a competitive advantage for manufacturers by indicating that the devices brought into circulation will remain in compliance even beyond the key date of June 1, 2012,” explained Wilfried Babelotzky, head of the CB test laboratory at BSI Group Germany.
For further information:
BSI - Germany, Healthcare
Eurocat Institute for Certification and Testing GmbH