The COVID-19 crisis has led to an increase demand for certain products: personal protective equipment (PPE) and medical devices. The European Commission has now taken urgent measures to restrict the export of particular products outside of the European Union, except where an export authorisation has been granted. The European Commission has also recommended that economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities take steps to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand.
Implementing Regulations on export of certain PPEs and medical devices
Implementing Regulation (EU) 2020/402 restricts the export of specific personal protective equipment set out in Annex I to the Regulation outside of the European Union. These products are used to protect the spread of infectious materials and though these fall into the following categories, the measures relate specifically to the product with the CN codes shown in Annex I:
- protective spectacles and visors
- face shields
- mouth-nose-protection equipment
- protective garments
- gloves.
The export restrictions do not apply where the exporter has obtained authorisation from the competent authority where they are established.
The European Commission published guidance on 19 March 2020 and have amended Regulation (EU) 2020/402 through a further Implementing Regulation of 19 March 2020. The amendments clarify that the export restrictions do not apply to exports to Norway, Iceland, Liechtenstein, Switzerland, as well as the overseas countries and territories listed in Annex II of the Treaty and the Faeroe Islands, Andorra, San Marino and the Vatican City.
The Guidance confirms that the UK should be considered as a Member State for the purpose of Regulation 2020/402, not a third country. It also clarifies the obligations around applying for an authorisation and further explains that the details of the application process will be determined by the Member States. Member States must notify the European Commission with the details of the National Competent Authority that will issue export authorisations.
The restrictions apply from 15 March 2020 for a period of six weeks in light of the rapidly developing COVID-19 crisis.
Commission Recommendation
Commission Recommendation (EU) 2020/403, published on 16 March 2020, invites economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand. Those measures should not have a detrimental effect on the overall level of health and safety.
The recommendations include:
Conformity assessment procedures
- Notified Bodies of PPEs should prioritise and swiftly conduct the conformity assessment activities in the framework of all newly submitted requests by economic operators of PPE necessary for protection in the context of the COVID-19 outbreak.
- Member States can make derogations under Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, regarding when the intervention of a notified body is not required.
Market vigilance
- Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.
- If 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 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.
- PPE or medical devices that do not bear a CE mark could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.
The laws and guidance around PPEs, medical devices, medicines and other healthcare products in response to COVID-19 is dynamic and further changes are likely to be seen as the situation develops.
Please contact Katie Chandler or Tasmina Goraya if you would like to discuss any of the issues raised in this article.
