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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