On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The Recommendation was adopted to tackle the increasing demand for personal protective equipment ("PPE"), such as face masks, gloves, protective coveralls or eyewear protection and medical devices, such as surgical masks, exploration gloves and some gowns, on the EU market. The Recommendation provides that under specific circumstances some medical devices and PPE may be made available on the EU market within the context of the COVID-19 outbreak, even if they do not yet bear the CE mark demonstrating conformity with applicable regulations and obligations.
On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the Recommendation is to ensure the availability of PPE and medical for adequate protection during the COVID-19 outbreak. The European Commission, therefore, invites all economic operators throughout the supply chain, as well as notified bodies and market authorities to deploy all the measures at their disposal to support the efforts to ensure the supply of PPE and medical devices throughout the EU market. The Recommendation underlines, however, that such measures should not have detrimental effect on the overall level of health and safety.
What does the European Commission recommend in relation to conformity assessment procedures of PPE and medical devices?
- The Recommendation encourages Notified Bodies conducting conformity assessment within the context of Regulation (EU) 2016/425 on PPE to prioritise and swiftly conduct conformities assessment activities of all newly submitted requests by economic operators for PPE that is necessary protection equipment within the context of the COVID-19 outbreak. The Recommendation also provides guidance in relation to PPE that are manufactured in accordance with technical solutions other than harmonised standards.
- With regard to medical devices, the Recommendation recalls the possibility for EU Member States to authorise derogations from conformity assessment procedures in light of Article 11. 13 of the Medical Devices Directive and, from 26 May 2020, Article 59 of the Medical Devices Regulation. The Recommendation recalls that these derogations are also available for Class I medical devices, where the involvement of a Notified Body is not required.
Non- invasive medical devices, such as surgical masks and gowns, are generally classified as Class I medical devices, unless other specific rules apply. For Class I medical devices, a self-assessment process and a related Declaration of Conformity by the legal manufacturer is required prior to CE marking of the device. In the Declaration of Conformity, the legal manufacturer of medical devices certifies that its product complies with the essential requirements provided for in Annex I to the Medical Devices Directive. In its Recommendation, the European Commission provides that the derogations procedures provided in Article 11.13 of the Medical Devices Directive and Article 59 of the Medical Devices Regulation can also apply to these types of medical devices.
What does the European Commission recommend in terms of market surveillance?
- According to the Recommendation, the market surveillance authorities or the individual EU Member States should, as a matter of priority, focus on investigation of non-compliant PPE or medical devices that raise serious risks to the health and safety of their intended users.
- In addition, the Recommendation provides a level of flexibility where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 on PPE or the requirements provided in the Medical Devices Directive or the Medical Devices Regulation. Within the content of COVID-19, the market surveillance authorities may permit these products to be made available on the EU market, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules. The Recommendation provides, however that this should be allowed only for a limited period of time and while the necessary procedures are being carried out.
- The Recommendation also provides that PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant EU Member State authorities. The EU Member State authority should, however, ensure that such products are only available for healthcare workers and solely for the duration of the current health crisis. These products must not enter the regular distribution channels or be made available to other users.
- The Recommendation requires that market surveillance authorities immediately inform the European Commission and other EU Member States of any temporary arrangement that they have granted to specific PPE or medical devices. For PPE, this should be done through the Information and Communication System for Market Surveillance (ICSMS).
This Recommendation is particularly relevant for manufacturers of medical devices and PPE that are in high demand in the context of the current COVID-19 outbreak and in relation to which the conformity assessment procedures, including the affixing of CE marking, have not yet been finalised.