Regulatory Update - Remote Audits for EU MDR/IVDR Certificates

Mi3 News


The European Commission has recently published (Jan 11th 2021) a Notice to confirm that Notified Bodies will be allowed to temporarily deviate from the requirement of performing on-site IVDR/MDR audits of a manufacturers' quality management system (QMS). This is a temporary measure that was taken in response to the extraordinary circumstances of the ongoing COVID-19 pandemic. The intention is that remote audits will be applied on a case-by-case basis following an objective review.

It is anticipated that these measures will only be in place for a limited period of time and on-site audits will be occuring again as soon as an easing of the current restrictions allow.

Make sure you are up to date and compliant

Mi3 provide comprehensive medical device regulatory consulting services. With Quality Management Systems certified and audited to ISO 13485: 2016 via the Medical Device Single Audit Programme (MDSAP) we have our regulatory experts on hand to support the commercialisation of your medical device.

Our systems are constantly evolving alongside the ever changing medical device regulations to ensure compliance to the most stringent standards within the industry. We regularly celebrate zero non-conformance audits from Notified Bodies and customers alike. Compliance, for us, is a MINIMUM requirement.

Partnering with Mi3 can help remove any uncertainty you may have within the regulatory landscape for your medical devices. Contact us today to find out how we can help.

The full notice from the European Commission can be viewed here


Previous Post Next Post
Mi3 News

Regulatory Update - IVDR Implementation Amendment

EU Commission’s proposed amendment to transition period of the In Vitro Diagnostic Devices Regulation (IVDR) calls for a progressive roll out.

Read more
Mi3 News

Student Placement Blog

In July 2021, Mi3 took on four students from different universities to participate in “A Year in Industry”. Over the course of the year, the students will post multiple blog entries here, to showcase their experiences, highlighting some of the key activities they are involved in.

Read more
Mi3 News

Amendment of MDR (EU) 2017/745|OJ L241/7 on 8th July 2021

On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal of the European Union with some changes and corrections, including, misprints, typos and translation errors.

Read more