IVDR Application Process – What do you need to know?

QAdvis have invited Charlotte Hess from BSI to give us some 
“need-to-know” when you plan for your IVDR-Application.

Charlotte has solid knowledge of the IVD industry and understands the complexity of the IVDR applications. Whether you’re starting the certification process, looking to transfer or just need to discuss options for your business, she can guide you efficiently through the process.

• Status Quo IVDR
• The Application Process
• The Certification Process
• How else can BSI support?

2023-09-12, 10.00 – 11.00 CEST, including time for Q&A.
The Webinar will be administrated in Teams.

Charlotte Hess, Senior Business Development Manager IVD EMEA North, BSI.
Charlotte has joined BSI in 2017. She’s is currently the Senior IVD Business Development Manager for Northern Europe, managing IVDR applications with BSI.


Local representative and what you need to know

Several countries require an in-country representative. This company is often chosen by the marketing department to market and distribute the medical devices in the country. But is this really the best strategy when it also includes being the regulatory contact with the authorities?

The marketing department is without doubt the best department to choose sales representatives and distributors. However, they may not be the best to evaluate if a distributor has sufficient knowledge of the regulatory requirements. Since the country representative is your spokesperson towards the authorities concerning registration, product changes and vigilance in some cases, they need to have appropriate knowledge about these issues. Additionally, manufacturers often depend on this company for keeping them up to date with changes in the local regulations and sometimes require assistance to determine if a product change need notification. This is not something you want to get it wrong.

But to be fair, you also need to see the selection of the distributor from the view of the marketing department. What’s the point of a distributor who knows the regulations by heart but wouldn’t be able to sell life jackets on the sinking Titanic.

Another important aspect to consider when choosing an in-country representative is that if you are dissatisfied with a distributor and wish to change, it can be a cumbersome and expensive endeavour if the distributor also is the registration holder. It can end up in a scenario where you will have to buy the registration from them or start the registration process from the beginning with a new distributor.

So, as always; Plan before Do.

Determine exactly what the local representative must be responsible for and limit the contract to those areas. If possible, determine that you, the manufacturer shall be the registration holder. If this is not possible, my advice is to use an independent regulatory affairs contractor as your licence holder. This way you can appoint whomever and as many distributors as you want. Obviously, the distributors will still have some regulatory obligations, but these would be limited to things like traceability and complaint/vigilance procedures. Authority contacts and registration updates would be routed through the RA-contractor. The RA-contractor can also be very helpful if the local health authority would like to do an audit on your facility which is not uncommon.

Noteworthy, is also the fact that the distributors often provide a template for what the Letter of Authorization should look like. This is very convenient, but make sure that you really want to give them all the authority that is described in the template. Additionally, it is a good idea to set an end date of the contract or a clause on how the termination should be conducted. This is to avoid any trouble in the future. Depending on the complexity, it can be good to have a legal person to review the contract before signing.

There are a lot of things to consider before you enter the new market, but to quote Arthur Miller; “The jungle may be dark, but it´s full of diamonds.”

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Finally, summer vacation!

During the late spring, the time for summer and for vacation can feel far away. But one thing is certain, it will always arrive and finally, now is the time to wrap up the first 6 months with a few words.

The medical device industry has been home to some of the most revolutionary innovations of humankind. Innovations have been a cornerstone for the advances in global health and there is a never-ending increase indemand for new medical devices.

During the past years, there has been some major trends attributed to the transformation of the medical device industry. As consultants we see an increased need for support with regards to Artificial Intelligence (AI), Machine Learning (ML), health apps, journal handling systems, wearable fitness medical devices, cybersecurity and more. New products are booming in the market, that hardly even existed ten years ago. AI and ML are becoming more common and continue to enable healthcare providers to detect or predict diseases, as well as enhance more personalized care for the patients.

Advanced technologies and the complexity of the regulations place great challenges on all stakeholders within the medical device sector. Both the regulatory landscape and latest technologies are in constant motion. Regulations, directives guidelines, standards keep getting revised or updated and development of technologies is now moving really quick. Authorities and notified bodies need to establish long term strategies to ensure that they can meet the future need for certifications and surveillance.

For us as consultants, we see a fantastic possibility to contribute with our solution-oriented knowledge and at the same time learn new innovations from our clients. To further develop our own services, we completed our ISO 13485 certification in May this year. This is a great milestone for all three companies within QAdvis group, and we are now even better equipped to meet our client needs.

Now when the summer is finally here and the “to-do-list” seems long, it might be difficult to take the first step into vacation-mode. But start with clearing your desk, write a list with remaining tasks, activate autoreply and just step out to the much long awaited recovery time during this, hopefully, warm and sunny summer weeks!

Finally, and most importantly, the whole QAdvis team would like to thank all our clients, partners, and employees for a content-rich, exciting, and challenging spring. We wish you all a lovely summer and look forward to continued collaborations after the vacation.

If you have any questions, don’t hesitate to contact us at info@qadvis.com  or annelie.hagstrom@qadvis.com


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