BIVDA and MedTech Europe are gathering information on the EU RoHS (including Northern Ireland), exemption pack renewal for Lead and Mercury in product type 8 – medical devices include those specifically for IVDs.
If you rely on the exemption packs for RoHS compliance to place products on the EU and/or Northern Ireland markets, then please let BIVDA know. MedTech Europe will require data and evidence to support the exemption pack renewals.
In addition, the equivalent exemption pack will also be due for UK RoHS, and companies placing product on the GB market will also need to consider how they intend to apply for exemption pack renewals, noting the £39,000 fee per exemption pack (split between applicants).
As previously discussed, MedTech Europe will not be submitting exemption pack renewals for the GB market. BIVDA can facilitate meetings to help co-ordinate submissions, but can not handle member money to facilitate payment of the UK RoHS fee. The UK Joint Trade Association (JTA), will also not be submitting exemption pack renewals, for exemption packs specific to the medical device/IVD sectors.
At the moment there is also a lack of transparency of applications to renew exemption packs, so we will have no visibility if or who has submitted any applications from outside of BIVDA, or the UK.
We hope to discuss this issue with the OPSS in the near future.
We would be grateful if members would complete and return this spreadsheet indicating which exemption packs they currently rely on to regulatory@bivda.org.uk by 6th September.
