Mar­ket sur­veil­lan­ce and con­for­mi­ty in the con­text of COVID-19: Part 2

Dri­ven by major pro­cu­re­ment initia­ti­ves on the part of the Ger­man govern­ment, as well as by Com­mis­si­on Recom­men­da­ti­on (EU) 2020/403 of 13 March 2020, mil­li­ons of coronavirus/SARS-CoV‑2 pan­de­mic respi­ra­tor masks (“coro­na­vi­rus masks”) have ente­red the Euro­pean and Ger­man mar­kets sin­ce Febru­ary 2020. The sta­ted goal of the­se efforts was to reme­dy the shorta­ge of per­so­nal pro­tec­ti­ve equip­ment in the health care sec­tor which was cau­sed by the spread of the SARS-CoV‑2 virus.

Sin­ce the Com­mis­si­on Recom­men­da­ti­on is not legal­ly bin­ding, and sin­ce it took weeks for sta­tu­to­ry rules to be adopted in this regard, respon­si­ble eco­no­mic ope­ra­tors in Ger­ma­ny were con­fron­ted with an unclear and high­ly vola­ti­le legal situa­ti­on as far as the sup­p­ly of masks was con­cer­ned. This was par­ti­cu­lar­ly true with regard to masks con­forming to the Chi­ne­se GB2626-2006 (KN95) stan­dard, which undoub­ted­ly accoun­ted for most of the masks which were pro­cu­red at the height of the cri­sis.

Until the Medi­cal Pro­ducts Sup­p­ly Ordi­nan­ce took effect, it could only be said with cer­tain­ty that the Cen­tral Body of the Ger­man Fede­ral Sta­tes for Pro­duct Safe­ty (ZLS) would issue test­ing prin­ci­ples for coro­na­vi­rus masks from time to time which allo­wed mask manu­fac­tu­r­ers to demons­tra­te an ade­qua­te level of pro­tec­tion. In addi­ti­on, masks which satis­fied US, Cana­di­an, Japa­ne­se or Aus­tra­li­an stan­dards were auto­ma­ti­cal­ly con­side­red eli­gi­ble for pla­ce­ment on the mar­ket. For a while, this assump­ti­on was appli­ed to Chi­ne­se KN95 masks as well, but the requi­re­ments for KN95 masks beca­me stric­ter over time, so that the­se masks may not be pla­ced on the mar­ket wit­hout a posi­ti­ve test­ing result from a CNAS-accredited test­ing labo­ra­to­ry.

It was not until the Ordi­nan­ce took effect on 27 May 2020 that the legal situa­ti­on beca­me clear. Under the Ordi­nan­ce, coro­na­vi­rus masks which fail to satis­fy US, Cana­di­an, Japa­ne­se or Aus­tra­li­an stan­dards may only be pla­ced on the mar­ket if

  • they ful­ly satis­fy the requi­re­ments of Regu­la­ti­on (EU) 2016/425; or
  • in case of a posi­ti­ve test­ing result in accordance with curr­ent­ly valid ZLS test­ing prin­ci­ples; and
  • con­fir­ma­ti­on from the mar­ket sur­veil­lan­ce aut­ho­ri­ty in accordance with § 9(3) of the Medi­cal Pro­ducts Sup­p­ly Ordinance.

The test­ing prin­ci­ples for masks will be remo­ved from the ZLS web­site at the end of 30 Sep­tem­ber. This means that, as of 1 Octo­ber 2020, it will no lon­ger be pos­si­ble to demons­tra­te an ade­qua­te level of pro­tec­tion using the ZLS test­ing principles.

Prac­ti­cal tips

Eco­no­mic ope­ra­tors which are still manu­fac­tu­ring and/or dis­tri­bu­ting coro­na­vi­rus masks will only be able to rely on the ZLS test­ing prin­ci­ples to demons­tra­te an ade­qua­te level of pro­tec­tion for a short peri­od of time. As of 1 Octo­ber 2020, the mar­ket sur­veil­lan­ce aut­ho­ri­ties will no lon­ger issue con­fir­ma­ti­ons affir­ming that masks are eli­gi­ble for pla­ce­ment on the mar­ket.

If coro­na­vi­rus masks can no lon­ger be tes­ted in accordance with the test­ing prin­ci­ples becau­se the remai­ning time win­dow is too short, it may be pos­si­ble to use them for other pur­po­ses, e.g. as mouth and nose pro­tec­tion (OP masks) for medi­cal per­son­nel or in the non-medical sphe­re; they may also be dis­tri­bu­ted out­side the EU. Pro­ducts which ser­ve as medi­cal face shields may also be eli­gi­ble for spe­cial appr­oval by the Fede­ral Insti­tu­te for Drugs and Medi­cal Devices (BfArm) as a medi­cal device in accordance with § 11 of the Medi­cal Devices Act.

Other­wi­se, respi­ra­tor masks may not be pla­ced on the mar­ket as of 1 Octo­ber 2020 unless they ful­ly satis­fy the requi­re­ments of Regu­la­ti­on (EU) 2016/425.


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