Hello All, I got an interesting set of questions: If the product, even though the same device, but co. Name has changed with a transfer of assets but with some of the same c-level executives, if they will need to consider the product now needs to meet the RoHS2 directive. See below discussion and questions.
They are producing the same medical device as pre 2014 requirement for RoHS2 exemption for medical devices but a new CE Mark as the co. Name has changed slightly. They still need to be able to sell the same product. See detailed questions below. Any specific guidance you can point too in this situation. I can’t find anything specific to this situation which wouldn’t say they are placing on the market newly or recently which means meeting the RoHS2 as a medical device because past the date of the medical device exemption transition of placing on the market (as a new co. Name with a new CE Mark) but I am hoping not needed as a huge set-back for them otherwise. Questions: 1) So, before the co. name change they originally “placed the product on the market” (CE Marked under MDD but as exempted Med Equip from the RoHS2) before the July 2014 exemption date. So, not CE Marked under the RoHS2. They are exempted with this original co. Name for the same product up til July 2019. No question this is ok. 2) They say the product came off the market in April 2015 but if the same device goes back on the market after that would it have to go thru “placing on the market” again as it already happened back before July 2014 (so originally placed on the market)? The question is 2 parted a) if the same co. Name as originally and b) with a new co. Name with the following background info. For them it would put them back a couple years of work to get a newly qualified device that also meets RoHS2 requirements: “Would the newly formed company STILL qualify? Here is the situation: UpXXXX MedXXXX Corp. (XXXX’s the same for both company names) was purchased, and everything became the property of the new owner with the one exception of the UBI number (business license number for US). Patents, product, model numbers, etc. were all purchased AS IS and will be used as such (so, we really will have the same exact model number). The newly formed company is named UpXXXX MedXXXX Technology Inc., and along with this also came the rights to have the same nomenclature to be able to identify ourselves as “UpXXXX MedXXXX”. Switching the UBI has caused us to need to get a new CE Mark under our new business name, however, we were given some help/streamlining from the NB since really the only changes are 1) Name 2) Address 3) Executive Management (and even that has 2 original members in it). We are working on getting our 13485 ISO Cert (Stage II audit coming early December).” 3) The existing product (mentioned in item 2) also has some parts that are end of life so they need to replace those parts but the part # or model # of the overall product will not change. The parts they are replacing with may be RoHS compliant so, will this impact the RoHS2 requirements for the product? Will it need to meet the ROHS2 requirements or can it still be exempt? To me this is closer to the requirement, but they would prefer not mention in their justification to the MDD NB nothing about parts being RoHS2 compliant in their justification. Thx much, Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: [email protected] Website: www.EisnerSafety.com *************** Internet E-mail Confidentiality Disclaimer *************** This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. Eisner Safety Consultants do not accept liability for any errors, omissions, corruption or virus in the contents of this message or any attachments that arise as a result of e-mail transmission. ******************************************************************************* - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
