This document summarizes regulatory plans and deliverables for achieving compliance with the RoHS2 directive for medical device products. It outlines adding a RoHS2 addendum to technical files to document compliance, assessing technical documentation, and reviewing engineering changes to ensure continued compliance. Key deliverables include obtaining internal approval of technical files and declaration of conformity for CE marking to allow placing compliant products on the EU market by the July 2014 deadline.
3. RoHS2 Addendum to Technical Files
– IAW EN 50581:2012 (Sec 4.3), each Technical File will be revised
(“RoHS2 Addendum”), to include the following section summaries for:
– Process Description
– List of Harmonized Standards
– Supplier Qualification Process
– Risk Assessment (supplier and material)
– Compliance Documentation
– Supplier Declarations
– Material Declarations
– Analytical Test Reports
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4. Technical Documentation Assessment
– IAW EN 50581:2012 (Sec 4.3.1), the Manufacturer shall undertake the
following four tasks:
– Determine the information needed (4.3.2);
– Collect the information (4.3.3);
– Evaluate the information with regard to its quality and
trustworthiness and decide whether to include it in the technical
documentation (4.3.4); and
– Ensure that the technical documentation remains valid (4.3.5)
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