Covid19 - Advice for Importers, Distributors and Purchasers of PPE Facemasks
There are different types of face masks used in different contexts in connection with the current COVID-19 outbreak. The Health & Safety Authority (HSA) is the National Market Surveillance Authority for Personal Protective Equipment (PPE) used in workplaces and the following information relates only to PPE facemasks.
PPE facemasks/respirators are designed to protect the wearer from exposure to airborne contaminants generated from work activities in workplaces.
Medical/Surgical masks are Medical Devices and not PPE nor are barrier masks or other face coverings designed to protect the public. Further information on the different types of face coverings and the relevant market surveillance authority responsible is available in the ‘Additional Information’ section below.
PPE used within the EU must comply with Regulation (EU) 2016/425, which was given effect in national legislation by the EU (Personal Protective Equipment) Regulations 2018 (S.I. No. 136 of 2018). These regulations cover the design, manufacture and marketing of PPE (including the duties of manufacturers, Importers and distributors) and define the legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. Before placing PPE on the market, a manufacturer must ensure that the PPE undergoes a conformity assessment procedure to demonstrate compliance with the essential health and safety requirements (set out in Annex II of Regulation (EU) 2016/425 or Schedule 2 of S.I. 136 of 2018).
FFP2 & FFP3 PPE Facemasks
PPE facemasks such as FFP2 and FFP3 are products falling into Category III PPE according to Regulation (EU) 2016/425. This means that an EU Notified body is required for the conformity assessment procedures, including a type examination by the notified body resulting in an ‘EU type examination certificate’, as well as production follow-up by an EU notified body. Once the relevant conformity assessment procedure has been satisfactorily completed, the products must be CE-marked, followed by the 4-digit identification number of the notified body (CE xxxx). The manufacturer must draw up a Declaration of Conformity for the product, which must accompany the PPE (or be made available via a web link), together with the instructions and information for use in the language of the country where it is placed on the market.
The European Commission in the context of the COVID-19 pandemic has published a guidance document to assist those interested in identifying if a product is lawfully placed on the EU market:
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
The following (non-exhaustive) list of required documents and items should be checked when purchasing PPE:
- PPE is accompanied by a valid Declaration of Conformity,
- PPE is accompanied by a valid EU type Examination Certificate issued by a relevant Notified Body and referring to relevant test report to EN149,
- The PPE and its packing have the number of an EU Notified Body after the CE mark to indicate the EU notified body who carried out conformity assessment of the PPE,
- The PPE bears a type, batch or serial no. allowing its identification, and which relate to the documents issued, and
- The importer’s name, registered trade name/mark and postal address displayed on the PPE or on its packaging or in a document accompanying it.
Only those EU Notified Bodies listed in the Commission’s NANDO information system are entitled to issue valid certificates, within their scope and competences. It is important to ensure that a Notified Body for PPE has issued the EU type Examination Certificate. It is possible to search for Notified Bodies on the NANDO website by number, name, country and by legislation. Many Notified Bodies have contact details and websites where the relevant information on their certificates can be found.
List of EU notified bodies for PPE
Misleading / False Documents
Recent experience indicates the need to be attentive to misleading or falsified documents as well as to counterfeit products. The European Safety Federation website has information on how to recognise counterfeit or fake PPE and false or misleading certificates. It also contains information on recent suspicious certificates for PPE.
EU Recommendation (EU) 2020/403
In response to the Covid-19 health crisis, the European Commission has published Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures. It has also published a guidance FAQ document on these Procedures. In this sense, national competent authorities of the EU Member States may authorise the making available on the market of some products, for a limited period and while the necessary procedures are being carried out, even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised. To assist in interpretation of the process the HSA has produced process flow diagrams, which along with additional information, is accessible on our website here.
Information on face coverings and the relevant authorities on the CCPC website:
Information about Medical Devices on the Health Products Regulatory Authority Website
HSA’s frequently asked questions on PPE:
The ‘Blue Guide’ on the implementation of EU product rules:
Safety Gate: the rapid alert system for dangerous non-food products (RAPEX):
European accreditation laboratories for facemask testing