MedTech Europe recently sent a letter to the Commission and the Consultant BIOIS on the RoHS Pack 27 Annex III lead exemption consultations (launched by the Consultant in Q4 2023).
DG Environment responded to MTE’s arguments and noted that “Electrical and electronic equipment (EEE) under category 8 ‘medical devices’ is often not comparable with EEE from other categories. As you say, this difference was one reason to allow in 2011 longer maximum validity periods for EEE under category 8 than for other categories.”
MedTech Europe Secretariat considers this statement to be positive, as it acknowledges the different nature of our technologies under RoHS, as well as the need for longer exemption validity periods compared to the other RoHS EEE categories.
The next steps in the process are:
- The consultant could potentially contact MTE and/or the exemption application applicants for additional input in the next few months.
- After the Consultant has prepared their recommendation report, the Commission will assess it and prepare draft Delegated Acts which would be launched for a 4-week public consultation – the timing for this however remains to be seen.
The above information is kindly provided by MedTech Europe.
Information on GB RoHS:
For UK RoHS Exemptions, Pack 27 covers the exemption packs which are marked as transitional. This implies that the renewal process started before BREXIT. Due to this the UK RoHS exemption pack renewal will reflect the final decision on the EU assessment, and will update according to EU legislation. Future exemption pack renewals in the GB however will be independent of EU RoHS (except for Northern Ireland who continue to follow EU RoHS). Instead they are dependent on exemption pack renewals being raised directly to support UK RoHS exemptions independently from EU RoHS exemption pack requests.
The important aspect is that the decision-making will be evidence-based rather than by opinion. If BIVDA members rely on the use of one of the exemptions covered by Pack 27, we would encourage members to gather and present evidence to support the need to renew the exemptions covered by Pack 27.
If members have any concerns or questions on the exemption packs, please send them to regulatory@bivda.org.uk.
