ROHS and CE Mark - Requirements for a Class IIa Medical Device

aeropel

Involved In Discussions
#1
Hello,

In order to get the CE mark for a Class IIa medical device - what is needed in testing or other for the medical device? Is it enough to get the RohS compliance declaration from the sub contractors (PCB mfctr, assembler etc) or do I need to submit my finished product to some lab testing?

Thanks
 
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aeropel

Involved In Discussions
#3
Thanks. I think my question was not clear: I know that I need the NB f rgetting the CE. what I meant - was the ROHS issue .
 

bio_subbu

Super Moderator
#4
Hello,

In order to get the CE mark for a Class IIa medical device - what is needed in testing or other for the medical device? Is it enough to get the RohS compliance declaration from the sub contractors (PCB mfctr, assembler etc) or do I need to submit my finished product to some lab testing?

Thanks
Hi

As the RoHS recast Directive (2011/65/EU) is now a new approach Directive with CE marking, you should include RoHS conformity assessment in the procedures for drawing up the Declaration of Conformity and the Technical file. As you know the Technical File should contain all the relevant information which allows control authorities to verify the compliance with RoHS requirements.

Regarding how to prepare the Technical File, EN standards are referenced in the “Article 16 of 2011/65/EU”, it gives you information how to do it. In practice you have to run a risk assessment of your suppliers. For trusted suppliers, a simple declaration could be enough & untrusted ones, chemical analysis by accredited labs could be the best option.

Article 16. 2) of 2011/65/EU) Presumption of conformity:

“Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of Article 4 have been performed, or which have been assessed, in accordance with harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the requirements of this Directive”.

According to the Commission standardization mandate “EN 50581:2012” - Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances”. The standard EN 50581 describes following three kinds of documents that can be used to demonstrate conformity to RoHS requirements:

1. Supplier declarations and/or signed contractual agreements.
2. Material declarations &
3. Analytical test results.
 
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