Guidance for business on PPE for consumer use during COVID-19 Crisis
May 1, 2020
Regulation (EU) 2016/425 and the Irish PPE Regulation (S.I. 136/2018) (the PPE Regulations) set out the essential requirements which must be met before personal protective equipment (PPE) products can be placed on the Irish market. The definition of PPE includes “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety.” The purpose of the legislation is to ensure that only PPE which meets the essential health and safety requirements is available.
The Competition and Consumer Protection Commission (CCPC) and the Health and Safety Authority (HSA) are the designated Market Surveillance Authorities (MSA) in Ireland for the purposes of Regulation (EU) 2016/425. The CCPC is responsible for the market surveillance of PPE for consumer use. The HSA is responsible for the market surveillance of PPE for workplace use. Further information regarding the HSA’s approach to PPE that is new to the market during the COVID-19 crisis, is available here.
PPE Regulations: Requirements for PPE
The PPE Regulations outline obligations which economic operators (importers, manufacturers, distributors, and authorised representatives) must comply with regarding PPE, within the scope of the PPE Regulations. The essential health and safety requirements (listed in Annex II of Regulation (EU) 2016/425 or Schedule 2 of the PPE Regulations) apply to all PPE within the scope of that Regulation. All PPE within scope must undergo a conformity assessment procedure, in accordance with its risk categorisation, to demonstrate compliance with the essential requirements.
The key statutory obligations of an importer include (this is not an exhaustive list) the following:
- Conformity Assessment: Before placing PPE on the market, ensure that the appropriate conformity assessment procedure has been carried out by an EU Notified Body. Ensure that the manufacturer has drawn up the technical documentation, is accompanied by a Declaration of Conformity, and other applicable documentation (for example a Type Examination from an EU Notified Body and a technical file containing design and manufacturing details, as appropriate).
- Check for Safety Standard Markings: Before placing PPE on the market, ensure that the PPE has an accurate CE marking, is marked with the applicable identification marks, and has the importers name and contact details.
- Instructions & Information: Ensure that the PPE is accompanied by instructions and information in English.
- Take corrective measures: Importers who consider or have reason to believe that PPE is not in conformity with the PPE Regulations must immediately take the corrective measures necessary to refrain from placing it on the market, bring the PPE into conformity, or to withdraw it or to recall it, as appropriate.
- Notify the CCPC: Where the PPE presents a risk, importers shall immediately inform the CCPC to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
- Retain technical documentation: The importer must keep a copy of the declaration of conformity for a period of 10 years after the PPE has been placed on the market at the disposal of the MSA and ensure that the technical documentation can be made available to that authority, upon request.
Recommendation (EU) 2020/403
PPE intended for consumer use is seeing exponential demand in Ireland, in the context of the COVID-19 crisis. In response to the crisis, the European Commission has published Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures (the Recommendation) to ensure that, in the context of COVID-19, availability of PPE matches demand, whilst continuing to provide an adequate level of protection of the users’ health and safety.
Under paragraph 7 of the Recommendation, for a limited time, if PPE meets the essential health and safety requirements, and provided conformity assessment procedures have been started via an EU Notified Body, PPE can be placed on the market, even if the conformity assessment (including affixing of CE marking procedures) has not been completed. However, all PPE must continue to be designed and manufactured in accordance with the essential health and safety requirements of the PPE Regulations.
As the MSA for PPE for consumer use, Paragraph 7 of the Recommendation provides that the CCPC may approve the placing on the market of PPE for consumer use without affixed CE Markings for a defined period of time, if the following conditions are met:
- The PPE is PPE for consumer use (and not PPE for workplace use which is outside the CCPC’s remit);
- There is documentary evidence to show that the PPE meets the essential health and safety requirements (for example; by demonstrating the PPE is in line with a relevant EU Standard or the standards referenced in the WHO guidelines);
- The PPE is in the process of conformity assessment with an authorised Notified Body (as confirmed by that body); and
- The PPE continues to comply with the other requirements of the PPE Regulations.
In making its determination, the CCPC may require samples of the PPE. If the CCPC is satisfied that the PPE for consumer use demonstrates the conditions above, the CCPC will authorise the PPE to be placed on the market in Ireland for a defined period, until the conformity assessment procedure is complete. The CCPC is required to notify the European Commission of any authorisations issued under this Paragraph 7 procedure.
Without this approval from the CCPC, PPE for consumer use must comply with the full requirements of the PPE Regulations before it is placed on the market.
Economic operators of PPE for consumer use with queries, or who wish to apply for this authorisation from the CCPC should contact us at firstname.lastname@example.org
Paragraph 8 of the Recommendation also includes a provision for PPE purchased by the Government/HSE for use by healthcare workers only. This type of PPE is outside the scope of the CCPC’s remit, as it relates to PPE for workplace use.
Further information is provided via the links below:
- Recommendation (EU) 2020/403
- European Commission FAQ on Commission Recommendation 2020/403
- A list of EU Notified Bodies are available here (NANDO Database)
- Information from the HSA relating to PPE for workplace use that is new to the market during the COVID-19 crisis is available here
- Information regarding Medical Devices should be directed to the Health Products Regulatory Authority www.hpra.ie
- NSAI – link to press release and link to the location of standards
This information will be updated as necessary.
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