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EU Cancels Conformity Assessment Exemption Procedure for Medical Devices and Personal Protective Equipment within COVID-19 Pandemic
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EU Cancels Conformity Assessment Exemption Procedure for Medical Devices and Personal Protective Equipment within COVID-19 Pandemic

EU Cancels Conformity Assessment Exemption Procedure for Medical Devices and Personal Protective Equipment within COVID-19 Pandemic

The European Commission has recently issued Recommendation 2021/1433 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The Commission Recommendation (EU) 2021/1433 contains provisions that terminate easing of the rules within conformity assessment procedure for personal protective equipment (PPE) and medical devices necessary in the context of the COVID‑19 outbreak indicated in Commission Recommendation (EU) 2020/403.

Thus, it states that starting from October 1, 2021 Member States’ market surveillance authorities should not give authorization to the PPE and medical devices that didn’t pass the conformity assessment procedure according to the relevant EU regulations to get the CE mark. Moreover, the PPE that received authorization within the procedure indicated in the Recommendation (EU) 2020/403 cannot be placed on the EU market from October 1, 2021. Medical devices can be put on the EU market without the CE mark only in the cases described in Article 59 of Regulation (EU) 2017/745. However, the PPE and medical devices with authorization based on the  Recommendation (EU) 2020/403 can be available only up to May 31, 2022 except for the items that are part of stocks used by healthcare workers, first responders, and other personnel involved in the efforts to contain the virus. Such items may be available up to July 31, 2022


The EU Commission assigns the EU market surveillance authority to carry out activities to ensure that all PPE and medical devices on the EU market are in full compliance with the EU Regulations and set the term by August 1, 2022.   


The new EU Regulation with the decision has been approved once it is clear that there are no significant shortages of PPE and medical devices on the EU market.


The full text of the Commission Recommendation (EU) 2021/1433 you can find here.


The information has been prepared by the GMA Consult Group team.

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.


October 26, 2021

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