Waste Electrical and Electronic Equipment Directive (WEEE) Affects Medical Devices

In the new Directive 2012/19/EU on waste electrical and electronic equipment approved on 04 July 2012, medical devices are involved in the recovery and recycling scheme as well, whilst the recovery and recycling target tightens in the Directive. Active implantable & infective devices are still excluded.

Time line and recovery/recycling target are summarized as below.

Minimum targets applicable by category from 13 August 2012 until 14 August 2015 with reference to the categories listed in Annex I:

for WEEE falling within category 8 (medical device) of Annex I,

- 70 % shall be recovered, and

- 50 % shall be recycled;

Minimum targets applicable by category from 15 August 2015 until 14 August 2018 with reference to the categories listed in Annex I:

for WEEE falling within category 8 (medical device) of Annex I,

- 75 % shall be recovered, and

- 55 % shall be prepared for re-use and recycled;

Minimum targets applicable by category from 15 August 2018 with reference to the categories listed in Annex III:

for WEEE falling within category 4 (large medical equipment) of Annex III,

- 85 % shall be recovered, and

- 80 % shall be prepared for re-use and recycled;

for WEEE falling within category 5 (small medical equipment) of Annex III,

- 75 % shall be recovered, and

- 55 % shall be prepared for re-use and recycled

EU medical device manufacturers have to implement the Directive, non-EU medical device manufacturers also have to apply through their Authorized Representatives or Distributors, if they tend to market the devices in EU.