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What Essential Clinical Evidence is Needed for Legacy Devices?

The Regulatory Shift: From MDD/AIMDD to MDR This shift has introduced more rigorous requirements for clinical evidence, impacting all devices previously CE marked under MDD or AIMDD. What are the key changes? What Clinical Data Can You Use to Support Your Legacy Device? Pre-market: • Clinical investigation reports of the… Read More

News

Test Labs Team People Behind the Progress: Growth in the Test Labs Team
Test Labs Successfully Completed ISO 17025 UKAS Reassessment
Test Labs Successfully Completed BSI Stage 2 Assessment Audits
Student Live Brief – 2025 Kick off session

Popular Articles

How to CE mark a Medical Device A Guide to Good Laboratory Practice (GLP): Everything You Need to Know BS ISO 15727: Measuring the Output of a UV-C lamp UV-C Light Test Method: is there a validated process to measure efficacy?

Insights  

Medical Technology UK – A Show Worth Showing Up For Image
Medical Technology UK – A Show Worth Showing Up For Image
Medical Technology UK – A Show Worth Showing Up For Image

Medical Technology UK – A Show Worth Showing Up For

Medical Technology UK – A Show Worth Showing Up For Let’s be honest – picking which events to attend is tricky, in a perfect world (with an unlimited budget), we’d say yes to everything! But for 2024 and 2025,…
By: Marianne Browning, Business Development
Delivering a ‘Net Zero’ National Health Service – Medical Device Impact
Delivering a ‘Net Zero’ National Health Service – Medical Device Impact
Delivering a ‘Net Zero’ National Health Service – Medical Device Impact

Delivering a ‘Net Zero’ National Health Service – What MedTech Needs To Deliver

COP27 Last year the UK hosted COP26, the latest in a series of UN summits on climate change designed to help participating governments agree on steps to limit human impact on our climate system and global rises in temperature.
By: Tautvydas Karitonas, MD
Meeting the MDR Deadline: Implications for UK Healthcare Image
Meeting the MDR Deadline: Implications for UK Healthcare Image
Meeting the MDR Deadline: Implications for UK Healthcare Image

Meeting the MDR Deadline: Implications for UK Healthcare

All currently valid Medical Device Directive (MDD) CE certificates are set to expire in May of this year, marking a critical juncture for EU and UK medical device manufacturers. This date holds significant weight as the EU Commission had anticipated…
By: Tautvydas Karitonas, MD
Do MedTech Events Still Matter? Image
Do MedTech Events Still Matter? Image
Do MedTech Events Still Matter? Image

Do MedTech Events Still Matter?

In-person MedTech events still matter. Despite busy schedules and a shift toward digital, the right conferences continue to deliver valuable insights and connections. Global markets are aligning around shared regulatory challenges, especially in reprocessing and biocompatibility.
By: Tautvydas Karitonas, MD
FDA Medical Device requirements: Everything You Need to Know Image
FDA Medical Device requirements: Everything You Need to Know Image
FDA Medical Device requirements: Everything You Need to Know Image

FDA Medical Device requirements: Everything You Need to Know

What does FDA do The FDA is responsible for regulating the manufacture, repackaging, relabelling and/or import of medical devices.
By: Toni Carlton, Head of Q&C
UKCA mark
UKCA mark
UKCA mark

How to obtain UKCA mark for Medical Devices

Regulating Medical Device in the UK – UKCA guidance Following the UK’s exit from the European Union (EU), medical device manufacturers wanting to obtain UKCA mark and place their product on the market in Great Britain (GB) must now comply…
By: Toni Carlton, Head of Q&C
Q1 Moves Fast – But We Moved Faster Image
Q1 Moves Fast – But We Moved Faster Image
Q1 Moves Fast – But We Moved Faster Image

Q1 Moves Fast – But We Moved Faster

Building Momentum in a Cautious Market I always say Q1 is the fastest quarter of the year. People return from the holidays full of fresh energy, dust off their strategic goals, and before they’ve even hit their stride – bam,…
By: Tautvydas Karitonas, MD

Instructions For Use  

FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5 Image
FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5 Image
FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5 Image

FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5

FDA Requirements for Reusable Medical Device Validation The FDA requires manufacturers of certain reusable medical devices to include validated instructions for use and validation data on cleaning, disinfection, and sterilization in their 510(k) premarket notifications. In this blog post, we…
By: Chris Sibanda, Study Manager
Dental instruments validation: Everything you need to know Image
Dental instruments validation: Everything you need to know Image
Dental instruments validation: Everything you need to know Image

Dental instruments validation: Everything you need to know

For successful dental instruments validation, evidence must be provided in relation to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related Instructions for Use (IFU).  Within the IFU, there must be a…
By: Toni Carlton, Head of Q&C
Reprocessing Orthopaedic Medical Devices
Reprocessing Orthopaedic Medical Devices
Reprocessing Orthopaedic Medical Devices

Reprocessing Orthopaedic Medical Devices: Everything You Need to Know

Reusable orthopaedic surgical equipment Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients such as orthopaedic surgical equipment. Medical devices intended for reuse are likely to be contaminated with patient tissue or…
By: Chris Sibanda, Study Manager
Dental instrument validation case study
Dental instrument validation case study
Dental instrument validation case study

Dental instrument IFU validation in under 4 weeks – Case study

Dental instrument IFU validation Test Labs was contracted out to test and evaluate the instructions for use (IFU) of a re-processable dental medical device (MD) as required by ISO 17664-1:2021 “Processing of health care products — Information to be provided…
By: Chris Sibanda, Study Manager
Medical Device Manual Cleaning: Everything You Need to Know Image
Medical Device Manual Cleaning: Everything You Need to Know Image
Medical Device Manual Cleaning: Everything You Need to Know Image

Medical Device Manual Cleaning: Everything You Need to Know

Medical Device manual cleaning If someone had told me 16 years ago that I’d still be manually cleaning items as part of my job, I’d have been quite surprised. It wasn’t so much about the cleaning itself, but more about…
By: Enrico Allegra, Head of Laboratory

Biocompatibility  

Medical Device Biocompatibility Testing: Everything You Need to Know Image
Medical Device Biocompatibility Testing: Everything You Need to Know Image
Medical Device Biocompatibility Testing: Everything You Need to Know Image

Medical Device Biocompatibility Testing: Everything You Need to Know

What is biocompatibility testing, and why should I conduct these tests on my medical device? Biocompatibility testing refers to a set of standards (ISO-10993) that defines the potential biological risks of a device upon encountering the human body, specifically evaluating…
By: Riwia Chetian, Laboratory Scientist
Exploring the Future of Skin Irritation Testing Image
Exploring the Future of Skin Irritation Testing Image
Exploring the Future of Skin Irritation Testing Image

Exploring the Future of Skin Irritation Testing

Exploring the Future of Skin Irritation Testing: Our Visit to MatTek Corporation in Bratislava Our team – Enrico, Riwia, and Sophie – attended a training session in Bratislava, Slovakia. Our destination was MatTek Corporation, where we participated…
By: Sophie Bell, Study Manager
In vitro biocompatibility testing – Skin irritation: Everything You Need to Know Image
In vitro biocompatibility testing – Skin irritation: Everything You Need to Know Image
In vitro biocompatibility testing – Skin irritation: Everything You Need to Know Image

In vitro biocompatibility testing – Skin irritation: Everything You Need to Know

What is in vitro testing and how is it different to in vivo testing? In vitro means ‘in glass’ which essentially refers to testing that occurs in glass vessels (e.g., test tubes), instead of in a human or animal (in…
By: Riwia Chetian, Laboratory Scientist
ISO 10993-18: Chemical Characterisation of Medical Device Materials Image
ISO 10993-18: Chemical Characterisation of Medical Device Materials Image
ISO 10993-18: Chemical Characterisation of Medical Device Materials Image

ISO 10993-18: Chemical Characterisation of Medical Device Materials

What is Chemical Characterisation? Chemical characterisation involves analytical techniques that determine the identity and quantity of the chemical components of a material. It is important to know what chemicals are present in a medical device, as well as in the…
By: Syeda Begum, Laboratory Scientist
How Design Changes Impact Biocompatibility in Medical Devices Image
How Design Changes Impact Biocompatibility in Medical Devices Image
How Design Changes Impact Biocompatibility in Medical Devices Image

How Design Changes Impact Biocompatibility in Medical Devices

Why Medical Device Design Changes Matter The ISO 10993-1 standard outlines scenarios where a biocompatibility reassessment is necessary after a design change: 1. Material Changes: Switching materials or modifying formulations can affect how a device interacts…
By: Sophie Bell, Study Manager

Compatibility  

Medical Device Safety Testing - Test Labs
Medical Device Safety Testing - Test Labs
Medical Device Safety Testing - Test Labs

Medical Device Safety Testing – MDR focus on material compatibility

What is material compatibility? Medical device safety testing includes material compatibility studies. Material compatibility is determining the resistance between a surface (or product) and disinfectant products and technologies. An adverse reaction resulting in incompatibility of different components can impact the…
By: Toni Carlton, Head of Q&C
IEC 60601-1 at Test Labs
IEC 60601-1 at Test Labs
IEC 60601-1 at Test Labs

IEC 60601-1: Everything You Need to Know

What is IEC 60601-1? First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the…
By: James Tolmie, Laboratory Scientist
Dental Product Material Compatibility Testing – Case study Image
Dental Product Material Compatibility Testing – Case study Image
Dental Product Material Compatibility Testing – Case study Image

Dental Product Material Compatibility Testing – Case study

What is material compatibility? Medical device safety testing includes material compatibility studies. Material compatibility is determining the resistance between a surface (or product) and disinfectant products and technologies. An adverse reaction resulting in incompatibility of different components can impact the…
By: Syeda Begum, Laboratory Scientist
Handheld Device Material Compatibility – Case Study Image
Handheld Device Material Compatibility – Case Study Image
Handheld Device Material Compatibility – Case Study Image

Handheld Device Material Compatibility – Case Study

The COVID-19 influence on cleaning practices As we are all aware, the consequences of the COVID-19 pandemic were wide-ranging and varied. In the world of medical devices, one impact in particular has been frequently overlooked: a pronounced increase in the…
By: James Tolmie, Laboratory Scientist
Student Live Brief – Improving Disinfection Protocols for Medical Devices Image
Student Live Brief – Improving Disinfection Protocols for Medical Devices Image
Student Live Brief – Improving Disinfection Protocols for Medical Devices Image

Student Live Brief – Improving Disinfection Protocols for Medical Devices

Live Briefs at ARU At ARU, Live Briefs are an integral part of the course assessment and an essential aspect of teaching. They offer students a chance to apply their knowledge to current issues, preparing them for future employment.
By: Tautvydas Karitonas, MD

Disinfection  

Air purification
Air purification
Air purification

Air Disinfection Systems Efficacy – What’s Behind Their Claims

What do air purification and disinfection systems do? Air purification and disinfection systems are being designed to effectively clean the air in the environment and reduce or inactivate harmful populations of airborne pathogenic microorganisms, aiming to provide significant assistance in…
By: Tautvydas Karitonas, MD
Environmental Sampling
Environmental Sampling
Environmental Sampling

Environmental Sampling Services: Why Every Health Trust Needs Them

Why does our Health Trust need Environmental Sampling Services? Monitoring your healthcare environment through environmental sampling is as essential to infection prevention and control (IPC) as maintaining rigorous disinfection and cleaning procedures. There are two ways in which environmental…
By: Enrico Allegra, Head of Laboratory
UV-C light bulbs
UV-C light bulbs
UV-C light bulbs

BS 8628 – Disinfection Using Ultraviolet Radiation

Ultraviolet (UV) irradiation has been known for decades as a terminal disinfection method, widely used in a variety of applications including healthcare, agriculture, water and food treatment, as well as in airlines and many other settings. Due…
By: Enrico Allegra, Head of Laboratory
Medical Device Disinfectant
Medical Device Disinfectant
Medical Device Disinfectant

Medical Device Disinfectant – CE Mark verification step-by-step guidance

What classification of medical device is my disinfectant? Annex VIII of the EU 2017/745 Medical Device Regulation (MDR) outlines the classification rules for medical devices. Application of these classification rules should be determined by the intended use of the device.
By: Toni Carlton, Head of Q&C
Test method for airborne disinfection
Test method for airborne disinfection
Test method for airborne disinfection

EN 17272 – Test Method for Airborne Disinfection

The importance of the EN 17272 test Healthcare-associated infections (HCAIs) are one of the biggest threats to the healthcare system. These infections are usually acquired after hospitalisation and manifest 48 hours after admission to the hospital. These infections are…
By: Enrico Allegra, Head of Laboratory

Electrical Safety  

Medical device material compatibility
Medical device material compatibility
Medical device material compatibility

Medical Device Material Compatibility – What is the impact of failure?

Medical Devices: Are they compatible with IPC? As a medical device manufacturer, your products contribute towards the treatment, care and recovery of millions of people around the world. But while they are designed to function reliably, many medical devices are…
By: Tautvydas Karitonas, MD
You Need Pre-Compliance Evaluation – here’s why Image
You Need Pre-Compliance Evaluation – here’s why Image
You Need Pre-Compliance Evaluation – here’s why Image

You Need Pre-Compliance Evaluation – here’s why

What is IEC 60601-1? IEC 60601 is a series of safety standards examining the safety and performance of medical electrical equipment. IEC 60601-1 is the general standard of the series: it includes the basic safety and essential performance requirements for…
By: James Tolmie, Laboratory Scientist
Laboratory Training Course
Laboratory Training Course
Laboratory Training Course

Medical Device Manufacturers, You Need This New Training Course: Here’s Why:

Laboratory Training Course for Medical Device Manufacturers We have been listening to our client feedback, and in response to market need, Lorit Consultancy and Test Labs have co-developed a laboratory training course specifically designed for medical device manufacturers. This course…
By: Toni Carlton, Head of Q&C
Good Laboratory Practice & Safe Medical Device Reuse Image
Good Laboratory Practice & Safe Medical Device Reuse Image
Good Laboratory Practice & Safe Medical Device Reuse Image

Good Laboratory Practice & Safe Medical Device Reuse

What is Good Laboratory Practice? Good Laboratory Practice (GLP) refers to a set of principles designed to be implemented within a testing facilities quality management system. These principles define the processes and conditions under which non-clinical health and environmental safety…
By: Toni Carlton, Head of Q&C
IEC 60601-1 at Test Labs
IEC 60601-1 at Test Labs
IEC 60601-1 at Test Labs

IEC 60601-1: Everything You Need to Know

What is IEC 60601-1? First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the…
By: James Tolmie, Laboratory Scientist