John,
It is not surprising because that is what was supposed to happen.
EU RoHS 2 Recast Directive was published on July 1, 2011 and entered into force as of July 21, 2011.
As for demonstrating compliance, it was faced out for few years as shown below.
For medical devices and monitoring instruments, it is due by July 22, 2014.
For IVDs, it is due by July 22, 2016.
For CE marking purposes, we are subject to all requirements, to the extent applicable, beyond the essential requirements.
As reasonably sufficient time (arguably speaking though) has been given to the industry, we may not be able to stand firm to push back.
However, it should be firm's best interest to cooperatively work it out with their notified body.
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http://www.regulatorydoctor.com Riner VA
United States
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Original Message:
Sent: 07-30-2014 10:30
From: John Beasley
Subject: Medical Electrical Equipment and RoHS (2) Directive
Who else has received the message (below) from an EU Notified Body? Are you accepting this, or have plans to push back? After reading Eucomed's guidance Delineation between the Conformity Assessment ... - Eucomed, I am interested in what US medical electrical equipment industry plans.
Thank you.
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John Beasley RAC
Founder and Senior Consultant
Medtech Review, LLC
Henderson NV
United States
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________________________________ Begin Message ________________________________
Dear Sir/Madam,
Re: Compliance to Directive 2011/65/EU
Restriction of the use of certain Hazardous Substances in electrical and electronic equipment (RoHS)
As you will know from midnight on 22nd July 2014 all Medical Electrical Equipment that is not exempt, is required to comply with the RoHS Directive before a CE mark can be applied and it is placed on the market.
This communication is to advise you, of the Notified Body's minimum expectations in the supply of data to be able to verify compliance.
| Requirement | What we need to verify |
| Declaration of conformity (Annex VI ) | 1.You will need to supply a Declaration of Conformity that meets the requirements of Annex VI of the RoHS Directive 2.It will need to be signed and dated by an identifiable individual |
| Summary Technical Documentation | The NB expects the client to supply some evidence to support their signed Declaration. This could be a single Technical Document (ref Article 7 Para c of the directive) which explains how you have complied with the directive requirements.
Evidence of compliance with the harmonised standard will also be accepted |
The Notified Body will assess RoHS compliance during the conformity assessment of technical documentation for all new applications and sampling of technical files for existing CE marked devices.
________________________________ End of Message________________________________