Euro­pean Com­mis­sion Rec­om­men­da­tion on Reg­u­la­to­ry Exemp­tions for COVID-19 Products

The Euro­pean Com­mis­sion pro­posed to exempt cer­tain med­ical devices and per­son­al pro­tec­tive equip­ment (PPE) urgent­ly required in the cur­rent COVID-19 cri­sis from reg­u­lar CE mark­ing require­ments. Ger­many and the UK have now fol­lowed this recommendation.

Ger­many and UK Implementations

The Euro­pean Com­mis­sion recent­ly pub­lished a rec­om­men­da­tion for mem­ber states that appre­ci­ates the chal­lenges that come up for Euro­pean health sys­tems in the course of the COVID-19 pan­dem­ic or Coro­na virus respectively. 

The rec­om­men­da­tion aims to help local coun­try author­i­ties in tak­ing mea­sures to bring crit­i­cal med­ical devices and PPE to mar­ket quick­ly. The med­ical devices direc­tive (MDD) and also the med­ical devices reg­u­la­tion (MDR) allow for dero­ga­tions of the CE Mark­ing process when this is deemed nec­es­sary by mem­ber coun­tries. At the same time, the Com­mis­sion made clear that no adverse effect on prod­uct safe­ty may occur due to a poten­tial derogation.

Against this back­ground, the Com­mis­sion men­tions the fol­low­ing products:

Med­ical devices:

• Sur­gi­cal masks 
• Explo­ration gloves
• Gowns
• Ven­ti­la­tors

PPE:

• Face masks
• Gloves
• Pro­tec­tive coveralls
• Pro­tec­tive eyewear 

In addi­tion, Euro­pean Com­mit­tee for Stan­dard­iza­tion (CEN) and the Euro­pean Com­mit­tee for Elec­trotech­ni­cal Stan­dard­iza­tion (CENELEC) have agreed to make impor­tant stan­dards that may be used for the man­u­fac­tur­ing of these devices freely avail­able. You may access the cor­re­spond­ing arti­cle here.

The ques­tion now is which coun­tries will fol­low the rec­om­men­da­tion and to which extent these and oth­er prod­ucts may be exempt­ed from CE Marking. 

Ger­many exempts cer­tain med­ical devices and PPE 

mdi Europa has learned from a reli­able source that the Ger­man Fed­er­al Min­istry of Labor and Social Affairs allows for the fol­low­ing exemptions:

• Pro­tec­tive eyewear
• Pro­tec­tive coveralls
• Sin­gle use gloves
• Sur­gi­cal masks
• Face masks

may be placed on the Ger­man mar­ket with­out a CE Mark, i.e. with­out hav­ing fol­lowed the cor­re­spond­ing con­for­mi­ty assess­ment pro­ce­dure if a man­u­fac­tur­er may prove mar­ketabil­i­ty for one or more of the fol­low­ing markets:

• USA
• Cana­da
• Aus­tralia
• Japan

Please note that these mea­sures will only be valid for the Ger­man mar­ket and in the con­text of the pan­dem­ic. They are thus time­ly lim­it­ed and should not be under­stood as a gen­er­al rule.

UK sets up spec­i­fi­ca­tions for ventilators

The UK MHRA has issued a notice stat­ing that they will tem­porar­i­ly allow for ven­ti­la­tors and ven­ti­la­tor com­po­nents to be placed on the mar­ket under sim­pli­fied con­di­tions. How­ev­er, MHRA made also clear that this pos­si­bil­i­ty will not per­sist beyond the dura­tion of the cur­rent COVID-19 cri­sis. The cor­re­spond­ing paper (PDF) may be found here.

Ger­many will allow cer­tain med­ical devices and PPE to be placed on the mar­ket with­out a CE mark for a lim­it­ed time. 

To sum­ma­rize, the doc­u­ment pro­vides spec­i­fi­ca­tions that must be ful­filled, espe­cial­ly with regards to clin­i­cal require­ments and usabil­i­ty. If these require­ments are ful­filled, prod­ucts may be placed on the UK mar­ket with­out a CE mark.

Should you have any ques­tions or con­cerns, please don’t hes­i­tate to get in touch.

Source: Medtech Insight (an Infor­ma product)

For fur­ther infor­ma­tion we warm­ly rec­om­mend our fol­low­ing tags and pages

• The mdi Europa Library Section
• Tag “Euro­pean Com­mis­sion“
• Tag “Guid­ance Doc­u­ments“