Mar­ket sur­veil­lan­ce and con­for­mi­ty in the con­text of COVID-19

The glo­bal COVID 19 out­break and the rapid spread of the virus across the EU has led to an expo­nen­ti­al increase in the demand for per­so­nal pro­tec­ti­ve equip­ment (PPERegu­la­ti­on (EU) 2016/425), such as face masks and pro­tec­ti­ve suits, and for medi­cal devices (Direc­ti­ve 93/42/EEC resp. Regu­la­ti­on (EU) 2017/745) such as sur­gi­cal masks and exami­na­ti­on gloves.

In order to address the pos­si­ble shorta­ge of the above-mentioned pro­ducts for health­ca­re pro­fes­sio­nals, the Com­mis­si­on recom­mends (Recom­men­da­ti­on (EU) 2020/403) a series of mea­su­res to make pro­ducts that do not meet the rele­vant for­mal requi­re­ments but still pro­vi­de an ade­qua­te level of pro­tec­tion available on the Euro­pean mar­ket in a time­ly man­ner. In par­ti­cu­lar, the Com­mis­si­on recom­mends the fol­lo­wing with regard to the con­for­mi­ty assess­ment pro­ce­du­res to be car­ri­ed out and the noti­fied bodies ent­rus­ted with them:

  • Noti­fied bodies should prio­ri­ti­ze and swift­ly con­duct the con­for­mi­ty assess­ment of PPE products.
  • The WHO recom­men­da­ti­on on the appro­pria­te sel­ec­tion of PPE may be used as a poten­ti­al source of refe­rence for PPE not manu­fac­tu­red in accordance with har­mo­ni­zed stan­dards, pro­vi­ded that an ade­qua­te level of pro­tec­tion is ensured.
  • Accept­ed tech­ni­cal solu­ti­ons which do not com­ply with har­mo­ni­zed stan­dards but pro­vi­de an ade­qua­te level of pro­tec­tion should imme­dia­te­ly be shared by the rele­vant noti­fied body with other noti­fied bodies in the EU.
  • Mem­ber Sta­tes should con­sider exemp­ti­ons from the con­for­mi­ty assess­ment pro­ce­du­res for medi­cal devices.

The Com­mis­si­on fur­ther recom­mends the fol­lo­wing for mar­ket sur­veil­lan­ce aut­ho­ri­ties:

  • (For­mal­ly) non-compliant PPE or medi­cal devices which nevert­hel­ess pro­vi­de an ade­qua­te level of pro­tec­tion or ful­fil their inten­ded pur­po­se should be allo­wed on the mar­ket for a cer­tain peri­od of time
  • The above-mentioned pro­ducts should be taken into account accor­din­gly in admi­nis­tra­ti­ve pro­cu­re­ment procedures
  • The com­pe­tent aut­ho­ri­ties should inform the Com­mis­si­on and other Mem­ber Sta­tes through the ICSMS sys­tem of the aut­ho­riza­ti­on to make such pro­ducts tem­po­r­a­ri­ly available

Prac­ti­cal advice

In par­ti­cu­lar, eco­no­mic ope­ra­tors who manu­fac­tu­re and/or dis­tri­bu­te pro­ducts which pro­vi­de an ade­qua­te level of health and safe­ty pro­tec­tion but curr­ent­ly offer them for a dif­fe­rent use or exclu­si­ve­ly out­side the EU and the­r­e­fo­re have not (yet) under­go­ne the rele­vant con­for­mi­ty assess­ment pro­ce­du­res can and should bene­fit from the recommendations.

Eco­no­mic ope­ra­tors should proac­tively approach the com­pe­tent aut­ho­ri­ties or bodies and have them check whe­ther their pro­ducts are cover­ed by the abo­ve Recom­men­da­ti­on. The­re is no doubt that the demand for the above-mentioned pro­ducts has increased. Howe­ver, the Recom­men­da­ti­on expli­cit­ly refers to for­mal­ly non-compliant pro­ducts and not to pro­ducts which are mate­ri­al­ly non-compliant and the­r­e­fo­re unsafe. In the cur­rent situa­ti­on, the lat­ter would crea­te an addi­tio­nal and avo­ida­ble risk for health care pro­fes­sio­nals, which must be avoided.

Final­ly, it should be noted that the EU Com­mis­si­on has made a num­ber of har­mo­ni­zed stan­dards for PPE and medi­cal devices free­ly available. The har­mo­ni­zed stan­dards can be down­loa­ded free of char­ge from the web­sites of the natio­nal stan­dards orga­niza­ti­ons.


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