Importance of completing Audits during COVID-19

News: 16 April 2020

On Friday 17 April 2020, the European Parliament adopted the European Commission’s proposal to postpone the implementation of the Medical Devices Regulation (MDR) 2017/745 by 12 months. This urgently drafted proposal to delay the MDR is in response to the exceptional circumstances associated with the COVID-19 pandemic and the potential impact it may have had on the MDR implementation.

The proposal now also has to be approved by the member states and published in the Official Journal of the European Union (OJEU) before it enters into force. This is expected to be by 26 May 2020 at the latest. Once in force, the new Date of Application (DoA) for the MDR will be 26 May 2021.

Without a doubt, this one-year delay will bring some welcome relief from the intense pressure on organizations, notified bodies and competent authorities to complete the MDD/AIMDD transitions and early renewals before the 26 May 2020. However, despite the postponement of the DoA, we will continue to employ our resources on critical devices in the context of the COVID-19 pandemic and conformity assessments under the MDR to ensure effective implementation of Regulation.

It is important to note that, although the DoA has been delayed by one year, the key deadline of 26 May 2024 when the Directive based certificates issued by notified bodies become invalid remains the same. We would strongly recommend that, to ensure timely certification, you work towards the original dates in your strategic regulatory plans.

We are not aware of any current plans to delay the DoA of the In Vitro Diagnostics Regulation (IVDR).

There is still a mountain to climb to ensure all products transition to the MDR in a timely fashion, so we recommend you maintain your current focus.

We would like to thank you all for your efforts over the last few years, and the patience you have shown through what are unprecedented times.

We hope you and your families are safe and well.

Gary Slack
Senior Vice President – Global Medical Devices