Publication of Regulation (EU) 2022/112

–A Risk based roll-out plan for certain In Vitro Diagnostic medical devices and In-house devices

On 28 January 2022 the Regulation (EU) 2022/112 (CELEX number 32022R0112), amending new and updated transitional provisions to the IVD Regulation (EU) 2017/746, was published in the EU’s Official Journal after being signed on 25 January 2022 by the Presidents of the European Parliament and Council.

That means that this amending Regulation is now binding in its entirety and directly applicable in all Member States.

However, the amending Regulation does not change any requirements of the original IVD Regulation. It only changes requirement related dates of application identified in IVD Regulation (EU) 2017/746 articles 110, 112 and 113 for certain IVD medical devices including in-house devices.

The purpose of Regulation (EU) 2022/112 is to prevent disruption of supply of essential healthcare products in the context of the COVID-19 pandemic. All manufacturers need to control how the amending regulation affects transition times for each device.

 

Welcome to QAdvis!

We are very pleased to welcome a new consultant, Nils Lidström to our QAdvis team!

Nils has a master’s degree in system engineering and over 25 years of working with software development, the last 6 years with medical device software development using agile methodologies. Key areas of expertise are regulatory requirements and how to adapt procedures and use tool-based support to achieve compliance while minimizing documentation workload. Nils is based out of QAdvis’ Stockholm office.

Read more about our services Software Quality Assurance.

We wish all our customers and partners a Merry Christmas and a Happy New Year!

Every day a child is diagnosed with cancer. But there is hope. More children than ever survive their cancer today.

We are proud to refrain from Christmas gifts and contribute to better health by supporting Swedish Childhood Cancer Foundation during Christmas 2021!

Read our Diploma (Swedish).

Link to the Swedish Childhood Cancer Foundation (Swedish).

Christmas Rhyme 4th Advent

Internal Audit (ISO 13485:2016 clause 8.2.4)

The fourth of advent is finally here,
and Santa is tired after an intensive year.
They now need to finally assess,
So they audit their entire QMS.

Santa needs to put together his most talented team,
and start with a well-planned audit scheme.
The Elves shall audit with a risk-based approach,
and Santa shall do his best to be a good coach.

Process input and output must be clearly defined,
and reviewed that everything is really aligned.
When all the requirements are accepted and OK,
Santa can send his application to a Notified Body.

Success comes with teamwork and competence,
but also, a great lot a of common sense.
Santa and his Elves can soon look forward to Christmas eve
and be satisfied with all they could achieve.