exceptions to the conformity assessment rules for PPE - updated 15/02/2021
To allow suppliers to bring PPE and medical supplies quicker to those who need them the most, the European Commission has published Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.
15/02/2021 : in several member states, the application of Recommendation (EU) 2020/403 has been ended. This means that only PPE that went through the full conformity assessment procedure as foreseen in Regulation (EU)2016/425 can be placed on the market, also for the healthcare sector.
See for the original text in different languages : https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1586260931727&uri=CELEX%3A32020H0403 with a corrigendum available here https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1586261134786&uri=CELEX:32020H0403R(01)
This recommendation is addressed to Member States that can, based on this recommendation, authorise the placing on the market of PPE not yet gone through the complete conformity assessment procedure as described in the PPE Regulation (EU) 2016/425 (see article 7 of the Recommendation) or not CE marked (see article 8 of the Recommendation).
There are clear conditions for these exceptions. In any case this Recommendation is only applicable to PPE (and other concerned products) that are relevant for the COVID-19 crisis and that are destined to the healthcare sector. PPE placed on the market for other destinations must fully comply with the PPE (and/or other applicable) legislation.
In order to clarify this Recommendation, the European Commission has published a Q&A. For instance in the answer Q5 (Are there any other standards that can be followed in order to produce protective equipment ?) these conditions are clearly stated. The current edition of the document is dated 27/03/2020 and is available in different languages on https://ec.europa.eu/docsroom/documents/40521. On 10/07/2020, a second version of the Q&A has been published on https://ec.europa.eu/docsroom/documents/42311
The first situation (see article 7 of the Recommendation) is where national market surveillance authorities conclude that PPE destined for the EU market comply with the essential health and safety requirements of the PPE Regulation (EU) 2016/425, but the conformity assessment procedures are not yet finalised. In that case, the market surveillance authorities can authorise these PPE to be placed on the EU market for a limited time and only for the concerned Member State, pending finalisation of the work of the Notified Body. This means that before doing so, the manufacturer or importer must seek the authorisation by the market surveillance authorities of his Member State or the destination Member State. Typically, the authorities will require test reports from an accredited laboratory and confirmation by a competent Notified Body that an application for type examination for the product is done by the manufacturer.
In the second case (see article 8 of the Recommendation), relevant PPE for COVID-19 can be placed on the market even if the certification procedures have not been initiated and no CE marking is present on the product. In this case there are strict cumulative conditions (so if one of the conditions is not fulfilled, it is not possible to use this ‘exception’) :
- PPE is produced in accordance with applicable EN standards or with another standard referred to in the WHO guidelines or another technical specification that ensures an adequate level of safety.
- The PPE are part of a purchase organised by the relevant Member State authorities
- The PPE are only made available to healthcare workers
- The PPE are only made available for the duration of the COVID-19 crisis
- Under no circumstances, the PPE are entering the regular supply chain and made available to other users than healthcare workers.
Also in this case, the authorities will require test reports from an accredited laboratory.
In both cases, other technical specifications than the (harmonised) EN standards can be acceptable. For the acceptable standards of other regions, the WHO guidelines are used as a reference.
In both cases, approval by the national authorities is necessary before placing the products on the market.
We remind importers (and other economic operators) that there are obligations described in the PPE Regulation. These obligations remain valid, also during the crisis. See article “what to do when importing PPE (e.g. FFP2 masks) to the EU ?”
A list of accredited laboratories in the EU for masks (both medical and PPE) can be found on the website of the European Accreditation organisation EA (https://european-accreditation.org/coronavirus-outbreak-accredited-laboratories-for-face-masks-testing/). Also the China National Accreditation Service (CNAS) published a list of Chinese accredited laboratories for masks and other concerned PPE on their website (https://www.cnas.org.cn/english/photonews/04/902561.shtml). In both cases check for which standards the laboratory is accredited.
See also guidance document "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" published by the EU Commission.
All links to the official text of the Regulation and the related guidance documents and information can be found on the designated PPE webpage of the European Commission DG GROW : https://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment/