The Euro­pean Com­mis­sion has con­tin­ued to work on guid­ance for man­u­fac­tur­ers and oth­er eco­nom­ic oper­a­tors of med­ical devices and per­son­al pro­tec­tive equip­ment (PPE) to pro­vide answers on spe­cif­ic ques­tions that arouse in the course of the cur­rent cri­sis. Fur­ther­more, cer­tain Euro­pean coun­tries have start­ed to pub­lish exemp­tions and spec­i­fi­ca­tions for COVID-19 rel­e­vant products.

The sit­u­a­tion is high­ly dynam­ic – it is thus very impor­tant to have an eye on the most recent devel­op­ments. Sup­ple­men­tary to our last arti­cle, “Euro­pean Rec­om­men­da­tion on Reg­u­la­to­ry Exemp­tions for COVID-19 Prod­ucts”.

Guid­ance for med­ical devices and PPE pub­lished in Europe relat­ed to COVID-19 

We would advise to look at the fol­low­ing guid­ance if rel­e­vant for you:

Nation­al con­sid­er­a­tions on COVID-19 relat­ed tem­porar­i­ly changes

As men­tioned in our pre­vi­ous arti­cle, the Euro­pean Com­mis­sion has rec­om­mend­ed to mem­ber states to make use of exemp­tions for prod­ucts that are urgent­ly need­ed in the cur­rent cri­sis. All eco­nom­ic oper­a­tors should care­ful­ly mon­i­tor the local require­ments in the local coun­ties of sales. 


The Ger­man Fed­er­al Insti­tute for Drugs and Med­ical Devices (BfArM) has pub­lished sev­er­al notes on face masks in the con­text of the COVID-19 pan­dem­ic. One arti­cle includes a deci­sion flow chart to deter­mine how masks falling either under the MDD or PPE Reg­u­la­tion will be reg­u­lat­ed in the cur­rent sit­u­a­tion. Please refer also to the exemp­tions we have men­tioned in our pre­vi­ous arti­cle. Anoth­er arti­cle clar­i­fies the dif­fer­ent types of masks and how these are reg­u­lat­ed in Germany. 

Up to now, the arti­cles are avail­able only in Ger­man. Please let us know should you require addi­tion­al information.


The UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) has been busy and pub­lished sev­er­al doc­u­ments as well.

In addi­tion to the spec­i­fi­ca­tions for a sim­pli­fied mar­ket access for ven­ti­la­tors and ven­ti­la­tor com­po­nents, the agency pub­lished a sim­i­lar guid­ance doc­u­ment for rapid­ly man­u­fac­tured CPAP sys­tems.

Final­ly, the MHRA has added use­ful guid­ance for IVD tests and test kits intend­ed for the diag­no­sis of the Coro­na virus. It includes spec­i­fi­ca­tions for cer­tain self-tests or point-of-care tests, which may give a good indi­ca­tion of what is gen­er­al­ly required in the EU these types of tests. 

In this con­text, the UK also requires man­u­fac­tur­ers out­side the UK to reg­is­ter their IVD test kits with a sep­a­rate reg­is­tra­tion form.

Sources: Web­sites of the Euro­pean Com­mis­sion, BfArM and MHRA

To com­ple­ment this arti­cle we rec­om­mend the fol­low­ing sources