Dec. 2023

Welcome to another newsletter edition. Your source for insights and updates in the conformity assessment of IVD devices at QMD Services. As we step into a new year of innovation and excellence, we are excited to share with you not just our achievements, but also tips, industry news, and stories of success. This edition contains news and updates on our services. Furthermore, we want to emphasize to you that our commitment to impartiality and patient safety extends beyond our services. It is our mission to advance patient safety and care. We want to optimise patient outcomes through ensuring device compliance to the IVDR and MDR, and by adhering to key principles and standards of medical device vigilance, post market surveillance, and device risk management. So, grab a cup of your favourite beverage, settle in, and join us on this journey of continuous improvement and excellence.

  1. IVDR Designation, one year on

  2. MDR Designation Status

  3. Industry training by Team-NB

  4. Three tips on how to speed up in the application process

  5. Revised Price List

  6. Revised Terms & Conditions

  7. QMD Services to offer conformity assessment activities for customers from the USA!

IVDR Designation, one year on

On December 22nd, QMD Services celebrates one year of being designated as a Notified Body under the EU IVDR. It has been an intense year of work. The preceding four years of preparation were tested against the reality of customer demands and operational processes. Over the last year QMD has built a broad customer base in many countries inside and outside Europe. We are still waiting to issue our first certificate, with several conformity assessment projects well on the way.

We are happy to provide a service whereby we check the Quality System certification of Economic Operators (Importers and Distributors) as required under clause 4 of Article 16 of the IVDR. To ensure there is no delay with getting products to the market, please take note of the expected timelines in the Regulations under Article 16. Importers and Distributors must apply for their certification with QMD Services at least six months in advance of the stipulated 28-day notice period.

MDR Designation Status

Over the past year we have put substantial effort towards achieving MDR designation. The workload has been tremendous, but we are eagerly looking forward to finishing the application process. We have already evaluated and appointed a considerable number of clinicians, product reviewers, and site auditors who have gone through an intensive training programme and are eager to start working!

QMD strives for a broad scope for MDR conformity assessment codes. As we are still in the designation process, and our application is still under review, we cannot publish specific information. Once designated, real work will begin and QMD will enter a period of organic growth!

Industry training by Team-NB

As a member of the Team-NB association, QMD Services is happy to recommend the industry training modules provided by the association. The training modules have been developed and are presented by panels of Notified Body representatives, who are also members of the Association. Please visit the Team-NB website to see what training is already available under both the MDR and the IVDR, there is also valuable other resources available from their website.

Three tips on how to speed up in the application process

  • The first information sharing touchpoint with your NB is critical. You will receive a form where you will specify your company and device information. Complete this form with care and ensure that the contents are accurate! Ensure you populate each field (including justifying when something is not applicable) to avoid delays as the NB project leaders require this information to make an accurate assessment. 
  • Draft your Technical Documentation (TD) (see Annex II for what is required) with the intention of making your data comprehensible to individuals unfamiliar with you or your product and present the documentation in a format that is both easy to read, search, and locate. 
  • Incomplete or incorrect information leads to feedback loops and longer and costlier conformity assessment processes. Notified bodies are not allowed to consult you but they are allowed and encouraged to explain their forms and processes. Therefore, thoroughly review and adhere to the instructions provided by the notified body.

Revised Price List

We have updated our pricing to consider the input from various stakeholders. This should contribute to the further provision of high-quality services while maintaining a sustainable and competitive business model. You find the updated price list on our webpage. The new prices come into effect for all services being provided from January 1st, 2024, on.

Revised Terms & Conditions

In addition to the pricing changes, we have also made some updates to our Terms & Conditions. The revised Terms & Conditions are available on our website and are applicable since November 1st, 2023.

QMD Services to offer conformity assessment activities for customers from the USA!

From January first, we will accept applications for conformity assessment of devices under the EU IVDR for device manufacturers who are based in the United States and who want to put their devices into the EU market. Initially, we will limit our offer to devices that are already approved by the US FDA.

In conclusion, and as we approach the end of 2023, we want to express our gratitude for your interest in working with QMD Services. It’s been an incredible year of growth and collaboration. We wish you a wonderful break over the holiday period. Best wishes from all of us at QMD Services. We look forward to continuing our work together in the coming year. Thank you for being a part of our journey!