New Blog available now on UKCA Consultation response from the MHRA. 

IVDEOLOGY

Friendly, Positive, Flexible, Compliant
The common-sense approach to quality and regulatory for the IVD industry

What is an IVD

In vitro diagnostics (IVDs) are a specific type of medical device, used for a medical purpose to help diagnose a medical condition or diseases for human patients. The difference between a Medical Device and an IVD is that IVDs use a human sample, like blood, urine, or nasal swab, to test for a specific medical conditions or state.

All IVDs that are used for this purpose must meet a series of requirements defined by local regulations in order to be used within each country or state. These regulations are defined by the local government, or competent authority. In the EU, this is identified by having a CE mark on the box.

The regulations for this type of device are continuously being updated to ensure that the tests being used are as safe and effective as possible. It is important that manufacturers, and any companies involved in the supply and distribution of IVDs, understand the regulations, and their responsibilities, for selling, importing and distributing IVD in the markets where the devices are sold and used.

The IVD industry is an innovative sector that through research and development, is delivering improved outcomes for the healthcare system economy and most importantly, patients.

IVDs are a vital component of all healthcare front line services and an integral part of almost all patient pathways. As such, the contribution of the IVD industry to the health and wealth of our nation should not be underestimated.

Our Services

We are proud to have a growing number of friendly industry experts who bring experience of quality, regulatory, technical and project management experience, to offer support to the IVD industry. 

Our team have developed their knowledge and understanding of the industry in various roles within the manufacturing, design and development of IVDs. This allows us to understand the complexities of quality and regulatory requirements from all areas of the IVD business. Our aim is to provide clear, pragmatic advice that helps non-quality and regulatory professionals understand the requirements. 

Our team of experts provide consultancy on many different disciplines, ranging from project-based roles, quality, or technical review or continuous, ad-hoc background support. We aim to be as positive and flexible as possible to meet our customer needs.

To help you learn, understand or develop your existing knowledge of the IVD requirements, we provide IVD training courses on key aspects of the IVD regulatory and quality. A unique part of this experience is the add-on group workshops where we can sit down and talk through your systems, or documents to further expand you knowledge, and really understand how to implement any learnings specific to your business needs.

For non-UK based manufacturers placing devices on the market in the UK, we offer an IVD UK Responsible Person (UKRP) service. We we walk you though the process of device registration and support any vigilance activity required. For IVD SMEs who do not have an established Quality or Regulatory department, we are able to support you to meet the new EU IVDR requirement for a Person Responsible for Regulatory Requirements (PRRC).

We collaborate with a network of like minded companies allowing us to offer a broad level of service to the IVD industry, and we continue to look for opportunities to establish strong connections throughout the industry.

UKCA Mark at IVDeology Ltd

UKCA

As of 1st January 2021, the UK has now left the European Union. 

For the UK IVD market, IVD devices will need to comply with the new UKCA mark from 2023. Manufacturers who are not based in the UK, will need to appoint a UK Responsible Person (UKRP), which is broadly equivalent to the EU Authorised Representative. 

Appointment of the UKRP should be made as soon as possible. New devices need to be registered within the MHRA Device Registration portal from the 1st January 2021, with the grace period deadline is the 1st January 2022.

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CE Mark at IVDeology Ltd

EU IVD Regulation

The regulatory environment for IVDs in the European Union is undergoing a period of significant change. From 26 May 2022, a new IVD Regulation came into force, this will result in safer and more effective IVDs being placed and used within the EU market. 

However this means that IVD manufacturers, importers and distributor have to take extra steps to make sure that they are compliant. This remains a big challenge for the industry and it is critical that the IVD industry plans for these changes now.

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Unit 22-23 The Joiners Shop,
The Historic Dockyard,
Chatham, Kent, ME4 4TZ