Author: Stuart Angell

On the 16th January, Biomed Alliance published a statement on “Urgent action needed to prevent widespread shortage of diagnostic tests”

BioMed Alliance – Statement: Urgent action needed to prevent widespread shortage of diagnostic tests (biomedeurope.org)

For anyone not aware of the current challenges facing the EU (and UK) IVD sector, it is well worth a read. The summary especially provides a really fantastic series of measures which are well worth thinking about. 

Their recommendations are: An urgent extension of the transition periods for all IVD classes will provide much-needed breathing room to the sectorEUDAMED must be fully implemented and widely used as soon as possible Special regulatory pathways to facilitate the conformity assessment of rare/niche/orphan IVDs should be created Additional efforts are required to raise awareness, and to provide support and guidance for IVD manufacturers, and particularly SMEs There is a need to simplify the re-certification of legacy devices, that have been successfully on the market without safety issues for a number of years There should be a legislative requirement for manufacturers to report to laboratory professionals and regulators when they intend to take an IVD or medical device off the market at least 6 months prior to withdrawalWhile, In-house IVDs (IH-IVDs) could fill the “CE gap”, Article 5.5, including the requirement of no equivalence to CE-IVDs, discourages their development due to the additional administrative burden and uncertainty of sustainability for IH-IVDs.

From my experience, we need to raise awareness, focusing on, but not limited to SMEs, as they will face the biggest challenge in compliance to the IVDR. 

Without making sweeping statements, I feel that it is not a question of SMEs won’t adopt IVDR, it is a case of SME’s don’t have the resources to make that significant jump to compliance. 

Given the additional competency, internal mechanisms required for understanding the new requirements, collecting and reviewing clinical evidence and maintaining this, SMEs struggle to gain sufficient investment, or sustain cash flow to support the 3 year + process of IVDR compliance. We have seen that the journey to compliance is possible, including for SME’s. However to do this requires a good understanding of what is required, a focused team and early planning to ensure that the key timelines are met.

We would encourage any IVD manufacturer, SME or not, who is looking to achieve CE marking to make contact with us. The more we are able to inform, encourage and engage with the industry, the more chance the industry has of preventing diagnostic test shortages.

Today IVDeology is 6 years old! With the knowledge of impending redundancy Stuart and I (Nancy) started the business that would grow to be who we are today. When we celebrated our first birthday in January 2019 we had no idear how our company woud grow over the coming 5 years or the amazing in vitro diagnostic designers, developers and manufacturers we would encounter and have the privilege to work with. 

So what have we achieved in our first 6 years?

IVDeology has grown to be a team of specialists who all work sharing our values Friendly, Flexible and Supportive.

We have built our Quality Management System which has just been recertified to ISO9001

We have worked with companies to deliver quality management services

o MDSAP Gap analysis/audit readiness

o ISO 13485 internal audits

o Building QMS systems to passing certification

o ISO13485 focussed training

o Audit support

We have worked with organisations who needed to add to their skills to meet the challenges of transitioning to comply with IVD Regulation 2017/746

o Gap Analysis

o Scientific Validity Reports

o Performance Evaluation Plans

o Performance Evaluation Reports

o Building Technical Documentation ready for review

o Group training events

o Company specific workshops – ask us anything

o One to one mentoring and upskilling

o Providing the Regulatory or Quality service until they onboard their own resource.

In 2020 we opened IVDeology UKRP Ltd to meet the neeeds of manufacturers outside the UK meet the requirements introduced by the UK MDR

So what changes have we seen in our 6 years of operation?

•  The continuing development of the UK regulatory framework, having Stuart working within BIVDA on the Executive Committee and as Chair of   the Regulatory Affairs Working Party gives first hand experience of those developing changes
• Regulatory deadlines have come and gone and been extended/modified and industry has had to adapt – we will continue to support in the transition
• Covid – This hit the IVD industry hard both during and after. Opportunity and distraction
• The accelerated development of AI into the IVD industry, we have a software regulatory focussed specialist on the team to support those developers needing regulatory advice.
• We have entered into some strategic partnerships to provide our customers with access to EU Authorised Representatives, Swiss Responsible Person support, Electronic quality management system software

We’d like to say thankyou to our team, past, present and extended and all of the amazing people and organisations we’ve had the pleasure of working with and continue to work with. We look forward to the next years adventures, we’d love to work with more of the industry so please do come and have a chat, no need is too small or too big – book time in with us by click here 

The MHRA have published a roadmap today which outlines the intended timelines for delivering the future regulatory framework for medical devices. Below is an Initial breakdown of the roadmap 

There are 5 key areas of the roadmap, broken down into:

1- Implementation of future regulations

The breakdown ensures patients have access is to life changing devices and tests and introducing them safely and within regulatory compliance, in a way that also continues to showcase the UK as being attractive to medical innovators. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025.

2- Transitional agreements

It has introduced legislation which provides that CE marked medical devices may be placed on the Great Britain market to the following timelines:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
• general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.

This will enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.

The legislation provides that you can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

• self-declared against EU MDR requirements (until 30 June 2030), or
• self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.
• It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.
  Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.

(Information above taken from GOV.UK website as of 9/1/2024)

3- Post Market surveillance requirements

The government have also introduced a list of requirements for manufacturers of devices for their post market surveillance once on the market (also known as PMS) in hopes to improve patient safety. The WTO website states that it intends to provide;

• Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
• Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
• More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.

4 – Future core regulations

During 2024, stakeholder discussion groups will be held to give early insight of the regulation policies of the future core regulations which will include:

– Ensuring devices have a unique device identification number (UDI)

– Improvements for implantable devices (class lll)

– Strengthening of QMS 

– Changes and updates of class devices including those acting as software as a medical device (SaMD) as well as cyber security requirements and AI software in line with those in the EU

– New requirements for clinical investigations

– Requirements for a Qualified Person within regulatory internally in the company

– Requirements for intended purpose statements to align with their device

We will continue to monitor the updates as and when they are released, but any queries or questions about the above updates can be submitted to us via [email protected] or you can book time into our calendar and chat with our friendly team about how this will impact your business – get in touch here