Hi Paul,
In addition to the general technical documentation file in line with the MDD, which include (but not limited to):
- General description of the product
- Documentation of Product design structure and information showing the relationship of conformity documentation with material, parts, and subassemblies in the product
- Risk assessment of materials, parts and subassemblies
- Conformity information on materials, parts, and subassemblies
- Manufacturing documentation and records
- Harmonized standards, specifications, and conformity procedures that have been applied to ensuring the conformity of the product
You should also be looking at more specific data to support RoHS compliance:
- Procedures/trainign and RoHS Responsibilities Assessment, including any RoHS program, compliance review, audit
- Bill of materials from suppliers, including things like declaration of conformity from the supplier, materials declaration and also supplier assessment
- Risk analysis/Risk assessment of Bill of Materials and Suppliers and risk mitigation data (ideally with refernce to the Rism management File, part of the technical file)
- RoHS testing, and storage
- Any information on compliance assurance system (CAS) with restricted substance controls (RSC) and other certifications , such as Environmental Certification
Hope this helps
Ana
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Ana Cruz
Johnson & Johnson Medical Ltd
Wokingham
United Kingdom
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Original Message:
Sent: 28-Mar-2017 10:26
From: Paul Martin
Subject: RoHS for medical devices. Technical documentation
I'm going to be doing a RoHS compliance audit for a series of medical devices for Europe. The 2011/65/EU indicates a need for technical files. What does the community suggest is sufficient technical documentation to demonstrate the claim of RoHS compliance?
Paul Martin
Quality Systems and Regulatory Affairs Specialist
P: +1.847.590.7175 | M: +1.989.698.6676 | paul.martin@rauland.com
Rauland is a Division of AMETEK, Inc.
1802 W Central Rd | Mount Prospect, IL 60056 | www.rauland.com