A Historic Day in the EU Life science industry as it welcomes the ‘New’ In-Vitro Diagnostic Regulations.
Exactly a year ago, the Medical Device industry welcomed the EU Medical Device Regulation where its predecessor – Medical Device Directive was transformed and reinforced as MDR – Medical Device Regulation.
While a lot has changed over the past year, medical device manufacturers still struggle to manage the turmoil, the phased enforcement of both IVDR and MDR can pose serious challenges.
As we all know the EU Regulation 2017/746 of the European Parliament and of the Council on in-vitro diagnostic medical devices (IVDR) entered into force on 26 May 2017. After a 5 year transition period, the IVDR will replace the EU’s current Directive on in-vitro diagnostic medical devices (98/79/EC).
Wondering what these regulations are?
The Key changes under IVDR include
Product scope expansion. Expanded scope covers diagnostic (including Internet-based) services, genetic testing and other tests that provide information about a patient’s predisposition to a specific disease or susceptibility for a medical treatment.
Reclassification of devices according to risk. Risk classes range from Class A for low-risk devices to Class D for high risk devices.
Premarket approval required. All device classes, except nonsterile Class A, are subject to approval by designated Notified Bodies.
Class C/B excluding Self-test, near patient test and Companion Diagnostics, are subject to assessment of Technical Documentation on a sampling basis. All other devices are assessed individually. For Class A sterile, the Notified Body assessment is limited to the assessment of sterility.
More rigorous clinical evidence. Manufacturers need to conduct clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class.
Identification of ‘Person Responsible for Regulatory Compliance’ (PRRC).
Implementation of unique device identification for better traceability and recall
Requirements for post market surveillance significantly increased and general timeline for reporting is reduced.
Greater Scrutiny of Notified Bodies.
No “grandfathering” provisions. All currently approved in-vitro diagnostic devices must be recertified in accordance with the new requirements.
Our Director and stalwart Regulatory Professional, Mrs Greer Deal, is constantly monitoring and identifying changes which will significantly impact the EU Diagnostic Sector, and has the following to say, “Diagnostic manufacturers have had a 7 year transition period to prepare for the Date of Application of the IVDR on Thursday 26th May 2022 but it’s clear that many are struggling to even understand the new requirements. This, however, is not the main rate-limiting factor. This particular ‘award’ belongs to the Notified Bodies in that only a handful have been successfully designated under IVDR. This is a huge challenge because at least 80% of Diagnostic Manufacturers will now need to engage with an EU Notified Body (previously it was only 10% to 20%) - you can imagine the queues! Fortunately, it has been agreed that IVDR should be a ‘soft’ implementation and therefore, additional transitional measures have been implemented to help ease companies into full compliance. This gives the sector some breathing space but this doesn’t mean you should ‘pause’ compliance activities. It’s critical that companies plan their strategy for achieving compliance and they must factor in the new timelines brought in by the ‘soft’ implementation of the IVDR. Be wary because some requirements under IVDR are mandatory as from 26 May 2022. If you are struggling to understand what your company needs to do, then you must seek expert advice. I promise you it’ll be the best investment you ever make! ”
As a part of IVDR Awareness, our experts organised a week long series of talks as the #IVDR Celebration week. A lot of information and tips were shared by various industry leaders and can be found here - https://med-di-dia.com/news/ivdr-celebration-weekTara Fahy, Regulatory Affairs and Quality Consultant raises some important points around the Quality Management System as a key attraction for IVDR. “It is paramount that you have a quality management system that fits your company and device. IVDR acknowledges that there is now a requirement to reduce risks where you can and continue to do so through innovation and improvement. Legal Manufacturers need to be able to show how their device meets the new requirements of the IVDR, while reflecting that compliance through QMS and designing a technical file that supports that action through clinical evidence and evaluation.The benefits of ISO 13485:2016, outlines quality management system standards for medical devices, include efficient cycle times, less waste and a reputation for top quality devices that can spread throughout the medical industry”, Tara added.
As a part of the celebrations, the Med-Di-Dia team has been helping diagnostic companies with a FREE 30-minute consultation and answering all doubts of the Manufacturers who also have the support of our ongoing and bespoke services. Claim your 30 Minute FREE consultation by sending an email at firstname.lastname@example.org
Many diagnostic manufacturers utilise various components and software within the product or have software as a medical device. Such medical devices have different regulatory requirements. Our Artificial intelligence and Machine Learning as a Medical Device expert, David Didsbury says the following, “Medical device software is getting a great deal of attention as the IVDR comes into force today. Previously Medical Device (IVDR or MDR) Software has been seen as the quick fix to issues or way of getting onto the market. The regulatory burden has increased dramatically with these new regulations and harmonised standards. Med-Di-DIA can help companies ensure that their internal processes meet all the requirements, for example, ISO 13485 clause 7.3, EN62304, ISO 1497, etc. Do you understand the new terminology - SAMD, ITMED, AI Machine learning etc.? Med-Di-DIA can provide a roadmap to regulatory compliance with independent software complexity.”
Navigating such complex regulatory requirements can be a challenge. Manufacturers around the World often have little understanding of the regulations in the European Union. Our experts support global clients with their EU market access by acting as an EU Authorised Representative [EU AR]. Want to enter the EU and need an EU AR? Contact US! email@example.com
Following David’s comment, it is important for SaMD manufacturers to focus on Cyber security! Our Cyber Security expert Paul Butcher highlights the following,“2017/745 (MDR) 2017/746 (IVDR), these two Regulations enhance the focus of legislators on ensuring that devices placed on the EU market are fit for the new technological challenges linked to cybersecurity risks. In this respect, the new texts lay down certain new essential Cyber safety requirements for all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves.”
While the IVDR is phased out and has long transitional periods, it is important for manufacturers to stay ALERT and navigate the regulatory maze with our experts.
Why are you sitting on the fence worrying about regulatory requirements? Med-Di-Dia is here to be your regulatory risk partner for medical devices, diagnostics and digital health!
Come and join the IVDR celebrations with us!
Welcome the regulations with #IVDRReady and create a safe and compliant product for the patient and end users.
Feel free to connect with us by sending an email at firstname.lastname@example.org
Why should regulations hold back your innovation?