News about GMP/cGMP

14.01.2021

EC allows remote audits by notified bodies

EC allows remote audits by notified bodies

On 11 January 2021, the European Commission (EC) announced what needs to be considered when Notified Bodies conduct remote audits of medical device and in vitro diagnostic manufacturers due to the COVID-19 situation.


In addition to the general delays caused by the pandemic, many manufacturers are increasingly concerned about the approaching deadlines for the MDR (May 2021) and IVDR (May 2022) coming into force.

The EC concluded that the need to prevent shortages of medical devices and in vitro diagnostics outweighs the risks of remote audits.

However, decisions should be made on a case-by-case basis. Travel restrictions and measures to control the pandemic in each country must be taken into account. A remote audit would be applicable where it "could prevent granting access or ensuring continued supply of devices to the market".

The EC points out once again that this regulation only applies as long as it is necessary and is not a blanket approval for replacing in-person audits with remote audits.

Notified bodies should take a risk-based approach and ensure that all of the manufacturer's technical documentation has been carefully reviewed. Details on how to perform remote audits are left to member states. Notified Bodies must inform the EC of the respective methods and the rationale for their use.


Source:

EC: Commission Notice


 

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