In light of the expanding impact of COVID-19 in the European Union (EU), the European Commission announced that it will postpone the implementation of new Medical Devices Regulation (MDR) for 1 year to May 26, 2021. The delay is designed to allow companies to respond to the urgent needs of member countries for medical devices and shortage of materials due to the insufficient number of existing medical device conformity assessment agencies.

The new regulation was originally planned to take effect on May 26, 2020 to replace the old medical device MDD.

The resolution has been welcomed by medical device manufacturers and certification bodies that have not yet obtained MDR authorization. Due to time constraints, most MDD institutions have stopped accepting new MDD applications in the past two months.

Due to the resolution, most MDD institutions will restart accepting certification. It also provides sufficient transition time for MDD institutions to switch to MDR ones.

On May 5, 2017, the EU issued a new version of the medical device regulation MDR (EU 2017/745), which came into effect on the 25th of the month. The old medical device directive MDD (93/42/EEC) and the new MDR (EU 2017/745) have an alternating transition period of three years.

Despite the delay in the official implementation of the new regulations, when applying for CE certification of medical products, Chinese export companies still need to carefully consider whether to use the latest regulations or the old directive scheme, and confirm the certification qualification of Notify Body (NB) organizations.

Recently, the European Safety Federation published an article on their official website that said they had learnt from different sources that "certificates" are used as the basis for CE marking of personal protective equipment (PPE) (including FFP2 and FFP3 masks), which have no legal value and cannot be used as confirmation of conformity assessment.

So far, the federation has seen such "certificates" on the letterheads of CELAB, ICR Polska, ISET, ECM, NPS, CIC, Amtre Veritas, and GTS. Whether these documents were actually issued by the above organizations is still unclear.

The federation has also published some details of such cases, which can be viewed on its official website at https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for -ppe.

The federation said that although it is imperative to bring as many masks and other related PPE into the EU as soon as possible in order to protect medical workers, it is unacceptable to provide inferior masks to medical workers who are taking high risks.

According to Regulation (EU) 2016/425, protective masks (such as FFP2 and FFP3) are Class III PPE, which means that conformity assessment includes:

1. The type inspection conducted by NB will be issued the EU Type Inspection Certificate, or Module B certificate for short.

2. Production tracking, random spot checks or system audits conducted by NB, referred to as Module D certificates or Module C2 certificates.

Therefore, at present, only certification bodies that have obtained the authorization of mask products' regulation Module B, Module C2 and/or Module D from the EU 2016/425 PPE are entitled to carry out CE certification of PPE masks.

On April 5, the State Administration of Market Supervision and Administration issued an information guide for the certification of masks and other anti-epidemic products for export to the EU and US markets.

The administration also published lists of eight certified institutions for CE certification for masks and other anti-epidemic products, and 44 institutions that can carry out medical device management system (ISO13485) certification in China.