COVID-19: risks in con­nec­tion with the import and dis­tri­bu­ti­on of respi­ra­tors and per­so­nal pro­tec­ti­ve equipment

The pre­sent coro­na­vi­rus pan­de­mic is crea­ting mas­si­ve shorta­ges in the sup­p­ly of medi­cal devices and per­so­nal pro­tec­ti­ve equip­ment (PPE) for medi­cal per­son­nel. Hos­pi­tals, phy­si­ci­ans and nur­ses are report­ing an urgent need for the­se items, par­ti­cu­lar­ly pro­tec­ti­ve clot­hing and respi­ra­tors. Glo­bal demand is out­strip­ping available sup­p­ly seve­ral times over.

Medi­cal device or PPE?

The ques­ti­on of whe­ther respi­ra­tors qua­li­fy as medi­cal devices and/or per­so­nal pro­tec­ti­ve equip­ment often can­not be ans­we­red with cer­tain­ty. Under the EU Medi­cal Device Direc­ti­ve curr­ent­ly in effect, devices which are desi­gned by their manu­fac­tu­rer for use both as medi­cal devices and as per­so­nal pro­tec­ti­ve equip­ment are requi­red to satis­fy the requi­re­ments of the EU PPE Regu­la­ti­on. Accor­din­gly, both medi­cal devices and PPE must under­go a con­for­mi­ty assess­ment pro­ce­du­re in order to ensu­re that they are safe and effec­ti­ve, and may not be sold on the Euro­pean mar­ket wit­hout a CE marking.

Recom­men­da­ti­on of the EU Commission

On 13 March 2020, EU Com­mis­si­on respon­ded to the pre­vai­ling shorta­ges in pro­tec­ti­ve clot­hing and respi­ra­tors by issuing a Recom­men­da­ti­on on con­for­mi­ty assess­ment and mar­ket sur­veil­lan­ce pro­ce­du­res for medi­cal devices and PPE and cal­led upon

  • all eco­no­mic ope­ra­tors throug­hout the sup­p­ly chain;
  • noti­fied bodies; and
  • mar­ket sur­veil­lan­ce authorities;

to take all available mea­su­res to adjust the sup­p­ly of PPE and medi­cal devices throug­hout the EU mar­ket so as to meet the ste­adi­ly gro­wing demand.

At the same time, the Com­mis­si­on cla­ri­fied that the­se mea­su­res may under no cir­cum­s­tances result in lowe­ring the gene­ral level of health and safe­ty, and that the health and safe­ty of users must con­ti­nue to be ade­qua­te­ly protected.

As a result, noti­fied bodies within the mea­ning of the PPE Regu­la­ti­on, Regu­la­ti­on (EU) 2016/425, are cal­led upon to prio­ri­ti­ze con­for­mi­ty assess­ment pro­ce­du­res for all new appli­ca­ti­ons invol­ving PPE which is neces­sa­ry for pro­tec­tion in con­nec­tion with COVID-19 and to con­duct tho­se pro­ce­du­res swiftly.

Addi­tio­nal­ly, the WHO’s recom­men­da­ti­ons for the sel­ec­tion of PPE should be accept­ed as a refe­rence for tech­ni­cal solu­ti­ons, even if they do not con­form to har­mo­ni­zed standards.

The mem­ber sta­tes are cal­led upon to exami­ne whe­ther they can aut­ho­ri­ze dero­ga­ti­ons from the typi­cal con­for­mi­ty assess­ment pro­ce­du­re for medi­cal devices.

While the acu­te shorta­ge con­ti­nues, mar­ket sur­veil­lan­ce is to focus on non-conforming PPE and medi­cal devices which pose a serious risk to health and safe­ty. Asi­de from devices in this cate­go­ry, the mar­ke­ting of for­mal­ly non-confirming PPE and medi­cal devices is to be aut­ho­ri­zed for the dura­ti­on of the cri­sis, alt­hough the Com­mis­si­on does not spe­ci­fy an exact peri­od of time. Spe­ci­fi­cal­ly, the refe­rence is to devices which have yet to under­go a con­for­mi­ty assess­ment pro­ce­du­re cul­mi­na­ting with a CE mar­king for mar­ke­ting within the EU. In “non-crisis times,” PPE such as medi­cal devices would have no chan­ce of ente­ring the Euro­pean mar­ket wit­hout a CE mar­king. The fun­da­men­tal requi­re­ment is that the rele­vant devices must be sub­stan­tively con­forming and the­r­e­fo­re safe. This is the case, for exam­p­le, for devices which have alre­a­dy been “appro­ved” in the US, Cana­da, Aus­tra­lia (P2), Chi­na (KN95), South Korea (1st Class) or Japan (DS) and which are alre­a­dy on the mar­ket in tho­se count­ries. Accor­ding to the Fede­ral Insti­tu­te for Occu­pa­tio­nal Safe­ty and Health, masks con­forming to the NIOSH’s N95 Stan­dard are the pre­fer­red alter­na­ti­ve to masks with a CE mar­king. Other pro­tec­ti­ve masks may also be pre­sen­ted to the noti­fied bodies DEKRA or IFA, whe­re they will be tes­ted in accordance with the sim­pli­fied test­ing prin­ci­ple based on the EN 149 standard.

Import and dis­tri­bu­ti­on of pro­tec­ti­ve mate­ri­als wit­hout CE markings

Based on the Commission’s Recom­men­da­ti­on, requi­re­ments for the mar­ke­ting of pro­tec­ti­ve equip­ment in the EU, par­ti­cu­lar­ly respi­ra­tors for medi­cal per­son­nel, have now been relaxed.

Howe­ver, the duties and requi­re­ments estab­lished by the PPE Regu­la­ti­on, Regu­la­ti­on (EU) 2016/425, con­ti­nue to app­ly for importers and dis­tri­bu­tors of devices wit­hout CE mar­kings (as of 30 March 2020) despi­te the impact of the cri­sis. Importers are still requi­red to ensu­re that the manu­fac­tu­rer has con­duc­ted the con­for­mi­ty assess­ment pro­ce­du­re. The Recom­men­da­ti­on may indi­rect­ly bene­fit importers and dis­tri­bu­tors in that the requi­re­ments for con­duct of the con­for­mi­ty assess­ment pro­ce­du­re its­elf are rela­xed. But this also means that importers and dis­tri­bu­tors which fail to satis­fy their duties under the PPE Regu­la­ti­on to ensu­re con­duct of a (sim­pli­fied) con­for­mi­ty assess­ment pro­ce­du­re could face cri­mi­nal and admi­nis­tra­ti­ve pen­al­ties as spe­ci­fied in the Ger­man sta­tu­te imple­men­ting the PPE Regulation.


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