PPE: Watch out for fake certification

It has been brought to the BPMA’s attention through a number of our members, including members of the Board, responding to a large volume of enquiries and requests to supply PPE or Personal Protective Equipment. It is estimated that global demand has increased 1000% in the past few weeks.

PPE can consist of several elements; face masks, gloves, hand sanitisers and protective clothing and as we reported in our BPMA weekly webinar last week not only must messages selling these products comply but the certification behind them as well.

It is vital that all PPE is made from appropriate materials and holds the relevant certification otherwise protection may be compromised.

As these types of products have medicinal or medical application, it is imperative that they hold the right documentation. With China starting to return to a ‘new normal’ and UK importers bringing goods into the country, the BPMA urges everyone to check out the documentation and certification very carefully to ensure all PPE is fit for purpose.

We are receiving reports that certificates provided to prove PPE products are suitable and have passed the rigorous testing required have either been changed or are not recognised by those who purportedly provided the certificates.

It is critical to validate PPE products to ensure those who receive them are not exposed to unnecessary risks and the PPE does the job it was intended for.

Validating the information: what to look out for (via European Safety Federation)

• In first instance the Declaration of Conformity (DoC) has to be provided and checked.
• For products imported from outside the EU (including EFTA and other participants to the single market), the importer has to make sure that the manufacturer has done the conformity assessment as foreseen in the PPE Regulation (EU)2016/425. 
• In case where there is doubt about the DoC, there is no DoC available or there is import from outside the EU, check the certification.

The European Safety Federation have also pointed out the ignorance of many entering the market due to demand commenting in a recent update; “We have the impression that manufacturers outside the EU (and probably even ‘newcomers’ and importers in the EU) are not entirely familiar with the EU Legislation on PPE and thus believe that by paying the ‘certificate’ from such an organisation,  they are fully in compliance with the EU legislation. And most likely, also on the side of the customers (including health authorities), the knowledge about the exact requirements of the EU legislation is lacking and thus they judge those documents as accurate.”

Please report any such instances to the BPMA as we collate a report on this topic.

Useful sources for information

https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/medical-devices-ppe/

https://www.eu-esf.org/covid19/4513-covid-19-suspicious-certificates-for-ppe