RoHS Exemption Declaration for IVDR instruments

Hello. I am first time posting here.

In other words, RoHS requirements are being reviewed for the IVDR class A electronic equipment under review. After checking with the original manufacturer(in asia), it seems that lead is used in the PCB SMT process.
What I'm wondering is, can it be covered under points 7 and 15 of RoHS Annex III?
If so, it looks like we can sell that equipment no later than July '23.
Whether sales have been banned since July 23, or whether products that have been cleared in Europe are available for sale.
If, even after customs clearance, it is impossible to sell, what will happen to the products that have already been sold?

Thanks in advance for your comments.

Hi Mikra,

I apologize for the late reply. As you probably know, RoHS (Restriction of Hazardous Substances) directives restrict the use of certain hazardous materials in electrical and electronic equipment sold in the European Union. Annex III of the RoHS directive lists general exemptions for specific applications or materials. However, Annex IV gives additional exemptions for medical devices (in vitro or not). Do you refer to Annex IV and not III? I am asking because, for example, point 7 of Annex III covers a family of exemptions. But points 7 and 15 of Annex IV are as follows:

• Exemption 7: "Equipment utilizing or detecting ionizing radiation - Lead stearate X-ray diffraction crystals."
• Exemption 15: "Others - Lead in solders for bonding to ultrasonic transducers."

For the equipment under review (In Vitro Diagnostic IVD class A electronic equipment), if lead is in use, it may be covered under these exemptions.
Regarding the timeline for selling equipment affected by RoHS regulations:

1. Deadline for Compliance: Both exemptions expired on July 21st, 2023, for in vitro diagnostic medical devices.
2. Ban on Sales After Deadline: After the compliance deadline (July 2023), if the equipment does not meet RoHS requirements, it may be prohibited from sale in the European Union unless specific exemptions or allowances apply.
3. Handling Products Already Sold: Products that have already been sold and are non-compliant with RoHS regulations may be subject to recall or other corrective actions as determined by regulatory authorities.

It's essential to consult with legal experts or regulatory consultants familiar with RoHS directives to ensure compliance and understand the specific implications for the equipment in question. Additionally, keeping abreast of any updates or changes to RoHS directives is crucial for continued compliance and business operations in the European market.
I hope this helps.