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.
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.