In the context of Covid-19 global outbreak, the European Commission (EC) published a Recommendation(EU) 2020/403 to the manufacturers, Notified Bodies and Competent Authorities on conformity assessment and market surveillance procedures to address the continuously increasing demand of 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 EC invites all economic operators to deploy all measures to assess such PPE or medical devices not bearing the CE marking allowing relevant Member State authorities to purchase them. However, these products are:
1. Only made available for the healthcare workers for the duration of the current health crisis;
2. Not entering the regular distribution channels and are not made available to other users;
While the health and safety of EU citizens is of upmost priority, the EC recommends extraordinary measures to authorise the making available of these critical products on the Union market to address the COVID-19 threat, however for a limited period of time and while the necessary conformity procedures are being carried out:
· All new requests submitted by manufacturers of critical PPE should be prioritized by the Notified Bodies (NB), which should swiftly conduct the conformity assessment activities.
· In the case of PPE products manufactured, following technical solutions other than harmonised standards, the WHO recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions. Nevertheless, an adequate level of protection shall be ensured, corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425.
· Relevant market surveillance Authorities should also evaluate if a non-CE marked PPE is compliant with the essential health and safety requirements laid down by the relevant Regulation (EU) 2016/425 in order to place such PPE on the Union market.
· Possibility for Member States to authorise derogations from the conformity assessment procedures for medical devices should also be considered, both under the current Directive, and the upcoming Regulation (MDR), and this even when the intervention of a NB is not required.
If you wish to place your PPE/medical device on the EU market and help us address the COVID-19 pandemic, Obelis Expert Consultants, having nearly 30 years of experience will gladly assist you!
Floriana Dibitetto
DPM-R&D Department
23/03/2020