Less than 9 months to go until Date of Application (DoA) for MDR, 26 May 2021. But is the DoA for IVDR, 26 May 2022 still practically possible?
The one-year postponement of DoA for MDR was a necessary move by the Commission. Notified Bodies have also during this extra year opened up again for possible renewal of existing EC certificate according to MDD.
During the spring and summer, over 20 new and revised guidance documents related to the new Regulations have been published by the Commission. Some are useful, such as the Clinical evaluation assessment report template and some provide less guidance than wished for.
The industry is awaiting publication of key IVDR guidance documents, for example on the classification of IVD which is fundamental for manufacturers in some cases to choose and plan a correct conformity route for CE marking. The MDCG IVD group has instead been forced this spring to put a lot of effort into addressing issues and regulatory questions related to COVID-19 IVD tests.
Currently only four Notified Bodies for IVDR are listed in the NANDO database to take on the huge industry demand. Lobbying activities against the Commission by industry organizations are ongoing for a postponement of IVDR. QAdvis take active part in these activities. It would be desired but there are no official signs at all at the moment from the Commission and there is an obvious risk for manufacturers to just wait and see.
Autumn 2020 is a lot about to manage the gray. Despite not having all the answers, decisions still have to made. QAdvis can support with this by preparing or creating the regulatory documents needed for MDR and IVDR based on the best currently available information and draft to-be-published guidance documents. We can also help to pre-assess the Technical Documentation in a Notified Body style manner, to minimize any negative surprises later on.
We also offer the service to take on the PRRC role for manufacturers that would like this to be managed by a trained and experienced regulatory professional.
To help you prepare for the implementation or get started with IVDR, we have a recently published a whitepaper
Pre-assessment of MDR technical documentation and quality management system
Review of technical documentation by a notified body ca be time consuming and expensive, adding a pre-assessment of the updated technical documentation to ensure MDR requirements are covered and allow for a faster review time by the notified body.
Our experts in technical documentation can make this review to help prepare and avoid common pitfalls. Delivering a review report with identified proposed actions for the technical documentation.
The quality management system also needs substantial updates adding MDR requirements, conducting an internal audit focusing on MDR will prepare your company for the notified body audits.
To ensure a successful implementation of MDR requirements and prepare for the notified body review and audit, QAdvis experienced consultants can support you with both technical file pre-assessment and MDR implementation audits. Read about our services here.
Person Responsible for Regulator Compliance (PRRC)
The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date, fulfilling the obligations related to post market surveillance as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released.
QAdvis can help you understanding the requirements or filling the role at your company. Read about it here.
QAdvis Academy provides both open courses and seminars and customer site specific training events.
Read more about our courses and seminars here.
Meet us in person
Camilla Drott has been an Quality and Regulatory Consultant at QAdvis since August 2018. We asked her a couple of questions about her work:
What is your area of expertise within the Medical Device industry?
I have 15 years of experience working with quality management systems; both from a regulator’s and manufacturer’s perspective. Creating, maintaining, and auditing quality management systems has therefore become my main area of expertise. I am a certified ISO 13485:2016 Lead Auditor with working experience from a Swedish Notified Body.
What is your best quality in your work as a consultant?
I think I am good at understanding my customer’s needs and keeping focus on what really matters in order to comply with regulatory requirements.
If you can only pick ONE piece of advice to give to your client, based on your expertise, what would it be?
One of the most important success factors for quality management systems is using a process-based approach. I have seen many examples of unclear distinctions between processes, procedures, and instructions, and this causes a great deal of confusion. The quality management system should always be designed after the business and be kept simple. Doing so will secure both compliance and effectiveness!
Where do you find recovery in your everyday life?
With three young kids and two cats there is not much room for recovery! But when there is, I enjoy listening to music, taking a long walk on Skåneleden or cooking something nice for my family. Read about Skåneleden here.
QAdvis Academy highlights
QAdvis Academy provides open courses and seminars as well as customer site specific training.
The course fee for our MDR and IVDR online courses includes one hour follow up session explicit to each participant for questions and discussions with one of our senior consultants.
We also cooperate on trainings with both Swedish Medtech and Intertek Academy.
IVDR and MDR – online
Courses intended for quality and regulatory professionals working with medical devices and in vitro diagnostic medical devices, as well as company management and other employees who needs to learn more about the impact and get a basic understanding of MDR and IVDR.
The aim is to give participants a basic understanding and useful tools when implementing MDR and IVDR.