Keeping medical devices in market and maintaining CE-marks

Dr Paul Hercock
Keeping medical devices in market and maintaining CE-marks - a guide to effective data collection

It’s no exaggeration to say that effective data collection is a cornerstone of a robust regulatory strategy under the MDR.

So much of working with the EU MDR concerns the harvesting, identification, appraisal and analysis of clinical evidence that, in the absence of effective data collection systems, the whole framework can become inefficient with ongoing regulatory approval becoming highly problematic.

Post-Market Clinical Follow-Up (PMCF) and Vigilance systems are vital components of Post-Market Surveillance (PMS) systems under the EU MDR. In this article, we consider steps that manufacturers can take to drive compliance with PMCF and vigilance data collection.

The following ‘golden rules’ guide all of our PMCF design services and underpin our success in driving ongoing investigator engagement and data collection compliance. For further information about our approach to maximising data collection compliance, read about our PMCF services or speak with a member of our team.

Effective data collection - the golden rules

Whatever the type of clinical data being collected - whether it’s PMCF data, complaints, or inputs into a formal clinical trial - there are several ‘golden rules’ that help maximise data collection compliance. In turn, adherence to these rules can help ensure that you have access to the clinical evidence you need for ongoing approval of your device.

1. Keep it simple

Perhaps the most important of all of the golden rules, it’s vital to keep datapoints simple and streamlined. It’s so tempting to add more and more datapoints, reasoning that the study will have more ‘value’ if questions are granular and detailed. In reality, time-consuming data entry forms are the quickest way to reduce data entry compliance and the worst way to encourage investigators to continue engaging with the study.

Rule 1 - Data points should be reduced to the minimum required to fulfil the objectives of the study. Questions should be simple to understand, unambiguous, and quick to answer. Unnecessary detail should be entirely eliminated.

2. Make data entry easy and convenient

Too many manufacturers rely on cumbersome, paper-based data collection systems. Paper based data entry suffers from numerous flaws that, in turn, will lead to patchy data collection. These flaws include:

  1. Paper can get lost or damaged and can easily fall into the wrong hands.
  2. Paper is slow to work with and must eventually be transcribed into a digital format for analysis, introducing a source of error or bias.
  3. Paper must either be physically transported from the clinical site to the study sponsor (or nominee) or digitally transcribed on-site, introducing a further reason for poor investigator compliance.

Well-designed digital data collection platforms overcome all of these problems and introduce a level of data security that is impossible to achieve with manual systems.

Rule 2 - Data collection should be through dedicated digital systems that are designed specifically for handling clinical data. They should be incredibly simple to use and should function from smartphone, tablet or computer. They should have low data and processor requirements and should not lag or fail. Digital data storage should adhere to the highest recognised standards relating to the handling and storage of clinical data.

3. Reward and support investigators

Clinical investigators are busy people. The truth is that every time a clinician or user enters data relating to your device, your are indebted to them for their efforts. Too many manufacturers begin to take investigators for granted; especially (and somewhat counter-intuitively) those who are the most prolific data enterers. This stems from the idea that compliant investigators will ‘take care of themselves’ and that efforts should focus on those who are proving troublesome to get up and running with the study. This is the wrong approach. In reality, 80% of your data will likely come from 20% of your investigators, and it is these who should be thanked, rewarded (compliantly) and encouraged.

Rule 3 - Focus on your best investigators and ensure they know that their efforts are appreciated. Do everything you can (compliantly) to demonstrate your ongoing gratitude for their efforts.

4. Ensure that follow-up requirements are reasonable

When designing clinical studies, it is tempting to plan for long-term follow-up of subjects that far exceeds that normally encountered in clinical practice. The allure of this is easy to understand - outcomes at ten years post intervention can generally be held to be more definitive than those at six months.

However, long-term follow-up requirements are a sure-fire way to find compliance with data entry waning over time. Before you know it, your ten-year follow-up study could have only a small percentage of investigators and subjects still participating in the study only a proportion of the way through its planned duration. While a reasonable middle ground will usually need to be found, it’s much better to have high compliance to a shorter follow-up than poor compliance to a longer one.

Rule 4 - Ensure that follow-up periods are sensible, appropriate and easy for investigators and subjects to work with.

Summary

These are some of the guiding principles behind the way we construct PMCF systems for our clients from across the industry. To find out more about our approach to PMCF and data collection in general, visit our PMCF service page or contact a member of our team for a no-obligation discussion.

This is Part 3 of our PMCF under the MDR article series. Subscribe to our Newsletter to ensure you don’t miss any of this comprehensive series.

Related articles

  1. Considering a medical device's intended purpose

    A medical device's intended purpose - what is the point?

    How do you define intended purpose, indication for use, intended clinical benefits, and claims?

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  2. Mantra Systems presents EnableChat, your AI-powered MDR & MDCG chatbot

    EnableChat - Your AI-powered MDR and MDCG chatbot

    Search the MDR and MDCG documents in seconds by asking EnableChat your questions.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  3. Searching adverse event databases for vigilance data

    Staying vigilant - A guide to searching for adverse events data

    We discuss the pros and cons of existing adverse event databases for vigilance data searching.

    Dr Simon Cumiskey Dr Simon Cumiskey Lead Medical Writer
  4. A doctor reading an SSCP document with a patient

    What is Summary of Safety and Clinical Performance (SSCP)?

    We explain what the SSCP is, when you'll need it and what its objectives are.

    Sandra Gopinath Sandra Gopinath Senior Regulatory Specialist
  5. A pile of question marks

    Medical Device 'Significant Changes' – Navigating EU MDR Article 120(3) using MDCG 2020-3 rev. 1

    Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).

    Shen May Khoo Shen May Khoo Junior Regulatory Specialist
  6. A signpost giving unsure directions

    MDR or IVDR - A sibling rivalry?

    A guide to easily understanding whether your device is a medical device or an in vitro diagnostic medical device (IVD).

    Dr Gayle Buchel Dr Gayle Buchel Lead Medical Writer
  7. An EU and UK flag

    What the latest Brexit U-turn means for CE Marking of medical devices in Great Britain

    Will Great Britain continue to allow the use of the CE mark for medical devices beyond the 2024 deadline?

    Dr Hanna Gul Dr Hanna Gul Lead Medical Writer
  8. A woman writing her own medical device regulation documentation

    Gain confidence, reassurance and control over your EU MDR strategy

    Find out how to build your own technical files within a guided framework while minimising financial outlays.

    Dr Gayle Buchel Dr Gayle Buchel Lead Medical Writer
  9. Racing to achieve MDR compliance

    Still racing to achieve MDR compliance? A transition period update

    On January 6th 2023, the EU commission has adopted the proposal to extend the transition rules of the EU MDR.

    Sandra Gopinath Sandra Gopinath Senior Regulatory Specialist
  10. A 7-step guide to navigating regulatory requirements for medical device start-ups

    A medical device regulations guide for start-up companies

    We present a 7-step guide to navigating regulatory requirements on a budget.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  11. An update on UKCA Marking of Medical Devices

    UKCA Marking of Medical Devices – An update on the status quo

    We review recently updated requirements for UKCA marking and what it means for your regulatory strategy.

    Dr Hanna Gul Dr Hanna Gul Lead Medical Writer
  12. How to choose a CER writer for your MDR Clinical Evaluation

    Choosing a CER writer for your MDR Clinical Evaluations

    We've compiled a list of considerations that will help you make the right choice when choosing a CER writer.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  13. Achieving MDR Compliance for Class I medical devices

    How to achieve MDR Compliance for Class I medical devices

    We outline a strategy for the regulatory compliance of Class I medical devices.

    Sandra Gopinath Sandra Gopinath Senior Regulatory Specialist
  14. Literature Search, SOTA Review and Clinical Evaluation

    Literature Search, SOTA Review process and Clinical Evaluation

    We help to demystify the process of systematic search & review of literature for Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath Senior Regulatory Specialist
  15. Literature Search Protocols & SOTA Reviews for medical devices and what to know before you start

    Literature searches and reviews for medical devices - what to know before you start

    We explain what you should know before beginning a literature search & review for your medical device.

    Sandra Gopinath Sandra Gopinath Senior Regulatory Specialist
  16. Five useful resources when writing a medical device CER

    Five useful resources when writing a medical device CER

    We outline five of the most useful and trustworthy Clinical Evaluation Report writing resources.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  17. Avoid pitfalls when writing a Clinical Evaluation Report

    Five common pitfalls when writing a Clinical Evaluation Report

    We illustrate five pitfalls when writing CERs and give you some tips to overcome them.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  18. How to make a medical device equivalence claim under the MDR

    Five tips for making a medical device equivalence claim under the MDR

    We'll show you what to keep in mind with regards to equivalance and Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath Senior Regulatory Specialist
  19. How PMCF goes beyond simple compliance - improving products and engaging customers

    How PMCF goes beyond simple compliance

    The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  20. PMCF systems for medical devices

    Why you'll almost certainly need a PMCF system for your medical devices

    We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  21. Ensure medical device regulatory compliance of your devices through Brexit

    The impact of Brexit on medical device regulatory compliance

    How to ensure regulatory alignment of your devices in the territories affected by Brexit.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  22. Use medical device regulatory consulting services to supercharge your MDR transition

    Is outside consulting support the answer to your MDR transition?

    Getting ready for the MDR is a demanding process. Outsourcing might be your solution.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  23. Increasing data entry compliance in PMCF studies

    Increasing data entry compliance in PMCF studies

    5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  24. Why medical doctors can drive MDR compliance

    Why medical doctors can drive MDR compliance

    Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.

    Dr Victoria Cartwright Dr Victoria Cartwright Relationship Manager
  25. Software as a Medical Device

    Software as a Medical Device

    Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  26. clinical investigator for pmcf eu mdr compliance

    Ensuring that clinical investigations work in practice

    How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  27. Coronavirus and medical device regulations

    Relaxing medical device regulatory requirements during a healthcare crisis

    During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  28. The new MDR compliance challenge

    The new MDR compliance challenge

    Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  29. Sources of Real World Evidence for MDR compliance

    Sources of Real World Evidence for MDR compliance

    At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer

More articles

Do you need help with your regulatory strategy?

Talk to us