Cer­tain types of devices must also ful­fill the require­ments laid out in the Direc­tives for envi­ron­men­tal aspects. More spe­cif­ic details can be found in the sec­tions WEEE and RoHS below.

WEEE – Waste Elec­tri­cal and Elec­tron­ic Equip­ment Direc­tive No. 2012/19/EU

The Waste Elec­tri­cal and Elec­tron­ic Equip­ment (WEEE) Direc­tive 2012/19/EU impos­es sev­er­al oblig­a­tions on pro­duc­ers of elec­tric and elec­tron­ic equip­ment, includ­ing elec­tri­cal and elec­tron­ic med­ical devices. The WEEE Direc­tive has been designed to reduce the amount of elec­tric and elec­tron­ic waste and to ensure the envi­ron­men­tal­ly sound take-back and recy­cling of these products.

Main require­ments for man­u­fac­tur­ers under WEEE

The man­u­fac­tur­er needs to:
1. Reg­is­ter with the nation­al author­i­ties;
2. Report to the author­i­ties the num­ber of prod­ucts put on the mar­ket;
3. Arrange for take-back and recy­cling of the WEEE;
4. Label the prod­uct with the ‘crossed out wheeled bin’ logo;
5. Design the prod­ucts in such a way that recy­cling is assured and made easy. The design has to be ‘recy­cling sound’.

mdi Europa has iden­ti­fied a ser­vice part­ner in order to sup­port our clients with the first three of the above require­ments. The fourth and fifth need to be tak­en care of by the manufacturer.

WEEE Com­pli­ance Process

  1. Appoint your Euro­pean Autho­rized Rep­re­sen­ta­tive
    → Ask for our quotation!
  2. Iden­ti­fy all EU Directives/Regulations applic­a­ble to your prod­uct (such as LVD, EMC etc.)
    → We will assist!
  3. Assure that your prod­uct falls under the scope of WEEE
    → We will guide you through!
  4. Define mea­sures for sep­a­rate col­lec­tion of WEEE
    → We will guide you through!
  5. Iden­ti­fy the applic­a­ble recov­ery rate for your prod­uct and define mea­sures to com­ply 
    → We will assist!
  6. Pre­pare nec­es­sary doc­u­men­ta­tion as defined by WEEE Direc­tive 
    → We will guide you through!

mdi Europa sup­ports man­u­fac­tur­ers of elec­tri­cal and elec­tron­ic med­ical devices to com­ply with the duties and respon­si­bil­i­ties defined by WEEE. 

RoHS – Restric­tion of Haz­ardous Sub­stances Direc­tive No. 2011/65/EU

The Restric­tion of Haz­ardous Sub­stances (RoHS) Direc­tive 2011/65/EU was ini­tial­ly adopt­ed in Feb­ru­ary 2003 by the Euro­pean Union. The RoHS Direc­tive took effect on 1 July 2006 and was refined, and is required to be enforced and become law in each mem­ber state. 

This Direc­tive restricts the use of six haz­ardous mate­ri­als (i.e. lead, mer­cury, cad­mi­um, hexa­va­lent chromi­um and cer­tain BFRs) in the man­u­fac­ture of var­i­ous types of elec­tron­ic and elec­tri­cal equip­ment. It is close­ly linked with the Waste Elec­tri­cal and Elec­tron­ic Equip­ment (WEEE) Direc­tive 2012/19/EU which sets col­lec­tion, recy­cling and recov­ery tar­gets for elec­tri­cal goods and is part of a leg­isla­tive ini­tia­tive to solve the prob­lem of huge amounts of tox­ic e-waste.

Source: wikipedia.org

RoHS Com­pli­ance Process

  1. Appoint your Euro­pean Autho­rized Rep­re­sen­ta­tive
    → Ask for our quotation!
  2. Iden­ti­fy all EU Directives/Regulations applic­a­ble to your prod­uct (such as LVD, EMC etc.)
    → We will assist!
  3. Assure that your prod­uct falls under the scope of WEEE
    → We will guide you through!
  4. Define mea­sures for sep­a­rate col­lec­tion of WEEE
    → We will guide you through!
  5. Iden­ti­fy the applic­a­ble recov­ery rate for your prod­uct and define mea­sures to com­ply 
    → We will assist!
  6. Pre­pare nec­es­sary doc­u­men­ta­tion as defined by WEEE Direc­tive 
    → We will guide you through!

Con­tact mdi Europa to find out about the cur­rent sta­tus at Euro­pean Com­mis­sion level.