Great possibilities ahead!

Just like 2020, 2021 has been a different and eventful year in many ways. In the shadow of the pandemic, the regulatory world has been spinning fast. New deadlines, challenges and possibilities are constantly attracting attention from us all. Remote work has opened the door for new ways of working, new contacts, and new ways to interact.

We have finally passed the date of application for the MDR and last month it was announced that there might be additional time for transitioning to the IVDR. More and more MDR certificates are being issued and the process is speeding up as we approach the end of the transition period. This past year, as a result of Brexit, manufacturers with devices in the UK have learnt how to register devices in the British market and how to work closely with a UKRP. New standards and guidelines have been published, the harmonization process is ongoing and additional guidance are on their way. The regulatory landscape is, as always, developing and moving, therefore training and learning is an important part of our daily work.

As consultants at QAdvis we are proud to be part of the process and to support our clients in several different ways, all leading up to the bringing of safe and effective medical devices to the global market.

The past year has been engaging, eventful, rich, instructive, challenging and much more. We are now looking forward to what 2022 will bring to us. Our team is strong and versatile, with new energy, and we have great expectations for the challenges ahead.

QAdvis UK Ltd.

We offer the service of a
UK Responsible Person (UKRP)

During the past year, QAdvis has started a new company, QAdvis UK Ltd., to be able to offer the service of a UK Responsible Person (UKRP) in the UK. The UKRP was introduced in connection with Brexit and the purpose is to act on behalf of manufacturers based outside the UK and perform specified tasks in relation to the manufacturer’s obligations. QAdvis UK has together with new and existing customers worked intensively to get their MD and IVD Technical Documentation reviewed, and products registered, thereby securing market access in the UK.

In connection with the deadline for registration of class IIa, IIb (non-implant), IVD List B and self-test IVD at MHRA on 31 August, approximately 1 million different products were registered. Now with the next deadline for registration of Class I, IVD General and Systems and procedure pack coming up (31 December), it can be expected that a significantly larger amount of products will be entered into the system.

The next challenge, and possibility, for access to the UK market is the UKCA marking, (UK Conformity Assessed marking) as the EU CE mark will no longer be recognized in the UK after 30 June 2023, the Medical and IVD Devices requiring a notified body in EU, will also need to be assessed by a UK-based approved body if they are to be sold in the UK. The UKCA are currently based on the requirements of the relevant Annexes to the Directives which are given effect in UK law through the UK MDR 2002 (as amended). Currently there are three UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). More are expected to be underway, but manufacturers should not wait too long to engage with a UK approved body, especially when considering the notified body bottleneck experienced in the EU.

UK market access for medical and IVD devices will continue to be challenging over the next couple of years, and QAdvis is, as always, poised to assist you in this endeavor.

Swedish Childhood Cancer Foundation

We refrain from physical christmas gifts and choose to support the Swedish Childhood Cancer Foundation (Barncancerfonden) in their effort to prevent and combat cancer diseases in children.

If you have any questions about our newsletter, please feel free to contact Hermine Redl, Office Manager, by phone on +46 8 621 01 05 or email here.

Meet us in person

Mikael Karlsson

What is your area of expertise within the Medical Device industry?
My expertise is developing, implementing, and maintaining QMSs compliant to relevant EU regulations and directives, especially IVDD and IVDR. It is best applied to customers within MedTech industry who need support in understanding regulatory requirements, implementing, or improving processes for product design and development, process validation, purchasing and supplier controls, and production controls in accordance with current 13485 standard and other applicable process or product standards such as 14971, 62366, 61010, etc.

What is your best quality in your work as a consultant?
I have a broad technical background with extensive hands-on experience in laboratory work, QC, production, product and process development from different industries. My engagement in start-up companies has made me understand many organizational and regulatory challenges customers face entering and growing within a regulated industry.

If you can only pick ONE piece of advice to give to your client, based on your expertise, what would it be?
Establishing your QMS and its processes with a clear scope using a risk based approach, always bearing your specific product/s intended use/s (or service/s) in mind, will make your day-to-day business in a regulated industry much easier.

Where do you find recovery in your everyday life?
I regain my power and entertain my well-being through physical activities. I am passionate about mountain biking on hilly trails in the forest, taking a short swim, or evening kayak tour in the nearby Baltic Sea.

Mikael has over 20 years of experience in product development and production from companies within Life Science and Space Technology. For the last 12 years he has been focusing on quality assurance and regulatory affairs applied to MD and IVD MD and establishing quality management systems compliant to applicable process and product standards for the EU market. Mikael holds a master´s degree in Materials Physics from Uppsala University and applies his broad industrial background and customer focus to find efficient solutions to customers´ quality and regulatory challenges.