Eucomed published guidance document on RoHS 2.0

S

SteveK

#11
Our ME products do comply and details (of how) have been added to our TF (where else to put it?), including a signed DoC to the RoHS 2 Directive (i.e. our CE mark now covers both Directives).

However, my NB is currently arguing (as of now, due to the 22nd July deadline) that they should indeed assess Technical Files (TF) to RoHS 2. I have been counter arguing along the Eucomed lines, even to the extent that in my correspondence I have put::argue:

?It maybe as a NB that you are infringing EU law by taking it upon yourselves to enact legislation (Directive 2011/65/EU) where you have no authority under NANDO registration or the member state?s regulative body.?

(I am still awaiting a reply on that one and also the fact they also may be in breach of our [conformity] contract).

Confusingly in an initial reply from our NB they have themselves indicated:

There is no Notified Body involvement in the directive as it is a manufacturer self-declare directive.


It is basically the principle I am arguing (again as per Eucomed) and the fact that NBs will be after more money to extend their review of TFs to include RoHS 2.

I would be interested on anybody else?s further take on this and/or similar experience directly with a NB.

Steve
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#14
We have also received a note from our NB saying that we need to submit RoHS documentation to demonstrate compliance. I take a similar view that it is out of their scope, but we are taking a more passive approach - we have the data, if they want to review it they can...as long as they don't charge more!

If however they issue a finding against RoHS that delays approval, I'm sure we will reconsider our approach
 
Thread starter Similar threads Forum Replies Date
bio_subbu Eucomed published revised guideline on Good Distribution Practice ISO 13485:2016 - Medical Device Quality Management Systems 3
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 UK Medical Device Regulations 1
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
A Timeline for harmonised standards to be published under MDR CE Marking (Conformité Européene) / CB Scheme 5
M Informational EU – Corrigenda for MDR and IVDR published in Official Journal Medical Device and FDA Regulations and Standards News 0
M Informational Corrigendum for the EU IVDR Published Medical Device and FDA Regulations and Standards News 0
M Informational Corrigendum for the EU MDR Published Medical Device and FDA Regulations and Standards News 0
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News Medical Device Directives – New templates for Field Safety Notices published Medical Device and FDA Regulations and Standards News 0
M Medical Device News Novas normas publicadas pelo ABNT/CB-026 / New standards published by ABNT/CB-026 Medical Device and FDA Regulations and Standards News 0
M Is there a published List of AIAG members requiring IATF certification ? IATF 16949 - Automotive Quality Systems Standard 2
M Medical Device News New guidance sheets for the MDR/IVDR published EU Medical Device Regulations 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
Richard Regalado ISO 31000:2018 is now published! Risk Management Principles and Generic Guidelines 0
bio_subbu CAMD published FAQs to the transitional provisions of MDR and IVDR EU Medical Device Regulations 0
Ajit Basrur Informational ISO/IEC 17025:2017 Published - November 2017 ISO 17025 related Discussions 8
M MDR and IVDR to be published May 5th 2017 EU Medical Device Regulations 14
S Use of Published IMDS Data from our Raw Material Supplier RoHS, REACH, ELV, IMDS and Restricted Substances 6
S 'Clean' Draft Medical Device Regulations Published EU Medical Device Regulations 0
M MEDDEV 2.7/1 rev.4 published - June 2016 EU Medical Device Regulations 42
bio_subbu Official Journal of EU published two new RoHS Exemptions EU Medical Device Regulations 1
M IEC 62366-1 published - March 2015 IEC 62366 - Medical Device Usability Engineering 7
T When will IEC 60601-1-2 Ed.4 be published? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M EN ISO 60601-2-22:2013 hasn't been published in OJEU yet Quality Manager and Management Related Issues 11
G What are the changes in the BS EN 1041:2008 recently published amendment Other Medical Device Related Standards 11
S Unannounced Audits - Commision Recommendation 2013/473/EU Published 25.9.2013 CE Marking (Conformité Européene) / CB Scheme 6
G New list (01-2013) of Harmonised Standards for The MDD published EU Medical Device Regulations 18
I New AIAG CQI guidelines published - Are they worth buying? Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna EMS auditor competence ISO Standard published - ISO/IEC TS 17021-2:2012 Miscellaneous Environmental Standards and EMS Related Discussions 1
S EU Medical Devices (Amendment) Regulations 2012 have been published EU Medical Device Regulations 2
Richard Regalado ISO 22301 was published 2012 May 15 - New Standard for BCM - Published! Business Continuity & Resiliency Planning (BCRP) 2
W MEDDEV: Qualification and Classification of Stand Alone Software Published EU Medical Device Regulations 4
AnaMariaVR2 GMP News: New Version of ISO 19011 on Auditing published Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
D Is ISO/TS 16949:2009 due for review and new edition to be published in 2012? IATF 16949 - Automotive Quality Systems Standard 6
RoxaneB Just been published! Coffee Break and Water Cooler Discussions 23
P New Renault CSR just published on the IATF Global Oversight webpage Customer and Company Specific Requirements 0
chris1price The final version of the RoHS2 recast was published last week as 2011/65/EU RoHS, REACH, ELV, IMDS and Restricted Substances 8
W MDDS Final Rule Published - February 15, 2011 US Food and Drug Administration (FDA) 0
bio_subbu CDSCO Published Draft version of Medical Devices Guidance Documents Other Medical Device Regulations World-Wide 3
bio_subbu Egyptian MOH published ?Draft Regulation for Medical Devices? Other Medical Device Regulations World-Wide 2
M IEC 60601-1-11 MEE used in Home Healthcare Environment Published IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
R ISO 10993-1:2009 incorporating Risk Management published by ISO ISO 13485:2016 - Medical Device Quality Management Systems 1
somashekar Revisions to the MDD 93/42/EEC published as Directive 2007/47/EC EU Medical Device Regulations 5
I IEC/TR 80002-1 Medical Device Software Part 1 has been published Other Medical Device Related Standards 7
bio_subbu Australia?s TGA - IVD Regulations have been published Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom