9 Steps to right first time regulatory compliance

It can be a scary thought, regulatory compliance.  So much to get your head around, so much to make sure is done right, and what is “right” anyway.

Wouldn’t it be handy to have a “crib sheet” to help you get there with less pain, in a shorter time, whilst simultaneously supporting development of a good medical device.

1. The right regulation?

May sound a bizarre first step, yet it is surprising just how many projects don’t adequately consider this question.

  • Be clear about the primary purpose for your medical device, and the mode of action.
  • Then, check the definition of “medical device” in the MDD (Article 1, 2 (a) through to (c)).
  • Does your product fit the description of a medical device? If, yes, then the MDD applies.
  • Does your product fit the description of an in vitro diagnostic device? If yes, then the IVD applies.
  • Does your product clearly not fit with any of the descriptions?  You can get advice (in the UK) from MHRA on borderline cases.  Similarly, you can access EU wide borderline device decisions, and the reasoning.

Remember to also consider other EU legislation that your product may need to comply with.  And, if you have an eye on other markets, look at how their requirements may differ from those of the EU.

2. Are you setting out to solve the right problem?

What is the problem or clinical need that your product is intended to resolve?  Is the problem widespread or isolated to a small aspect of healthcare in one country?

Answering this question will clarify the potential market size and clinical pathway(s) where the device can be used.  Your focus is then narrowed onto developing a product to address a specific need.  You can always expand into other clinical pathways or markets with a future version of the product.

Ultimately, you’ll have started to flesh out the product’s “Intended Use”, the bedrock upon which development rests.  Get this right, and the foundation is secure.

3. Put a Quality Management System in place

Arrival of the Medical Devices Regulation (MDR) explicitly requires a Quality Management System to be put in place for all classes of Medical Device.

The difference between the lowest risk medical devices and the higher classes is one of QMS certification.  For the Class 1, non-measuring, non-sterile medical devices, a manufacturer self-certified QMS is perfectly fine.  Otherwise, a Notified Body certification is needed.  Make sure you adopt the correct QMS certification route for your device.

4. Good Development Practice

“Begin with the end in mind” as Steven Covey said.  As you develop your device, picture how the documentation will come together for the submitted device.

The Design History File and Risk Management activities will tell the story of development, demonstrating why and how you arrived at the eventual solution.

The Technical File will provide the complete dossier of information that describes the medical device manufacture, assembly, testing and release requirements.

Robust, applied Documentation Control and Change Control ensure that you minimise the opportunity for surprises popping up at the end of development.  Start Change Control at an early stage in development, so design decisions are captured and can be referred to easily when answering regulatory authority questions on the submission.

Traceability Matrices should be your (new) best friend – they’re invaluable in ensuring that you’ve covered all the bases during planning, designing, testing and reporting.  If they’re created as you go along, headaches will be smaller than if gaps are spotted when the matrix is created at the end of development.  You may even consider a matrix for the Essential Requirements, to ensure you have documented evidence of compliance with each one.

5. Use Harmonised Standards

Check the most recent update to the European Commission’s list of Harmonised Standards, to see which are relevant for your medical device.  Manufacturers or conformity assessment bodies can use them to demonstrate that products, services or processes comply with relevant EU legislation.  So following the content of a Harmonised Standard is usually the straightforward route to demonstrating compliance.

6. Take care constructing your Technical File

Make it easy for the reviewer to navigate your Technical File, from a high level overview through to the detailed content that they’ll want to read through.  Adopt a logical layout to presentation of information.  There’s a handy template for the content of your Technical File provided by IMDRF (for a medical device, and for an in vitro diagnostic device).  The IMDRF documents are a few years old now, however the MDR contains a detailed description of Technical File content in Annex 2.

7. Your Clinical Evaluation Report

It won’t have escaped your notice that the MDR includes explicit requirements for Clinical Evaluation and its reporting.  There are two major benefits to getting underway with your Clinical Evaluation early in development:

1. The results of your research feed directly into the definition of Design Inputs (what the device needs to be able to do for the user / patient),

2. You have a clear picture of any Clinical testing that is required for the device, permitting realistic budgeting and planning of the project.

8. Post-market Surveillance Plan

Ensure that your QMS incorporates a good system for Post-Market Surveillance (PMS), covering vigilance activities, steps taken for pro-active PMS as well as reactive PMS (i.e. when you’re alerted of a problem, perhaps via a complaint), post-market clinical follow-up.  Naturally, all this is supported by a plan for PMS, that pulls all these threads together and demonstrates how information will be used to instigate or confirm design changes, how PMS information feeds into CAPA, Change Control and Complaint Handling processes.

9.  Managing Devices in the field

Remember to include activities to provide for CE Marking of your medical device prior to placing it on the market (for Class I non-measuring, non-sterile, this can be self-managed, for all other Classes, a Notified Body must be involved).

Consider what requirements you have for any servicing, maintenance and performance verification while the device is in service, and across its in-use life.  These will need to be documented and tested to verify their effectiveness in ensuring continued device performance and safety.

Getting it right, first time

There can be a lot to take in, working through these 9 steps.  Rest assured, help is at hand, should you wish for some guidance or support along the way.  Get in touch today, so we can explore how best to ensure you reach your goal of regulatory compliance, right first time.

Improving Paediatric oral medicine delivery – workshop

Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories

11th September 2018, London, United Kingdom

The workshop is likely to be of interest to many of our readers, so here’s information provided by the organisers:

The European Paediatric Initiative (EuPFI) is inviting expressions of interest in a workshop organised to identify and discuss challenges and potential improvements in the development, control and utilization of oral dosing syringes and enteral accessories for paediatric liquid medicines.

The workshop which will be held at University College London (UCL) School of Pharmacy premises in London, is a crucial step to find the optimal path towards correct dosing to all paediatric patients using these oral administration devices. A broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia, are invited to the workshop to share current practices and issues regarding the development and handling of oral dosing syringes and enteral accessories, to facilitate awareness and identify areas for improvement. Representatives from national competent authorities, EU institutions and other stakeholders will also attend.

Completed forms for expression of interest to attend the workshop should be submitted by 20th July 2018.

Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations, and so please do not book travel arrangements until your attendance has been confirmed.

Further details are available at http://www.eupfi.org/devices-workshop/

We have submitted our expression of interest in attending, and hope to see you at the workshop.

Is it “wellness”, or is it a device? Software as Medical Devices in the EU

The buzz surrounding the development and use of smartphone apps and other software to “manage healthcare” and “wellness” isn’t going away any time soon.

It is a situation that creates significant headaches for people developing software that may, or may not, be viewed as (part of) a medical device. Uncertainty that presents significant risk to their development plans, activities and investment, especially when the software part of the product sits on the cusp of the medical device space.

Earlier this year, we discussed how the FDA’s approach to this rapidly evolving market segment was bringing clarity (if you’d like a refresher, you can read the article here).  Let’s turn now to the approach taken in the EU.

EU treatment of software as a medical device

Developers have often referred to the MEDDEV Guidelines, as tools to help interpret the requirements of directives/regulations for medical devices.  The guidelines have been regarded as just that, and not legally binding – so there hasn’t been certainty over how well they interpret EU law.  But, now there is a legal ruling from the EU Court of Justice (CJEU) on the grounds for classifying software as a medical device.

Essentially the CJEU ruled that software is a medical device if it has at least one functionality that allows its use for a medical purpose set out in the definition of a medical device in the MDD (as amended):

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • Investigation, replacement or modification of the anatomy or of a physiological process,
  • Control of conception

The software does not have to work directly in or on the human body to be classed as a medical device.  The purpose of using the software is important, rather than the manner in which an effect is produced to the human body.

Why this should matter to you

The CJEU decision validates the criteria in MEDDEV guidance for classification of software medical devices, so they can be relied on with greater confidence both by the industry and regulatory authorities.  Developers of medical devices that are entirely or partly software can use the MEDDEV decision tree with confidence.

Determining if Software is a Medical Device or IVD

MEDDEV 2.1/6 includes a handy decision tree to help you determine if your software is a medical device:

Click to enlarge

There’s a similar decision tree to help you determine if your software is an in-vitro diagnostic device:

Click to enlarge

As you might expect, the devil is in the detail, for both of these classification routes.

Reducing and Managing Risk

The CJEU ruling means that development projects can have a greater degree of confidence that they’re applying the correct classification to their products, and hence massively reduce the risk that their activities are inadequate to satisfy regulatory authorities. The ultimate benefit is in avoiding unnecessary costs, unwarranted testing and use of resources, whilst ensuring that, for those software that are truly medical devices, sufficient testing and documentation are provided to demonstrate regulatory compliance.

You may find it useful to seek an independent, expert opinion on the outcome of using the decision trees for classifying your software development, before embarking on an expensive and lengthy programme.

If you would value a conversation to get the ball rolling, get in touch with us today.


Medilink Innovation Day 2018, and a Prize Draw

Our team had to pleasure of, once again, attending Medilink East Midlands’ Innovation Day earlier this month.

Unusually for industry conferences, there’s a broad mix of people attending Innovation Day, from academia, industry and the NHS, along with a variety of exhibitors – all of which make for an interesting day’s conversations.

A steady stream of visitors to our stand (we were there will colleagues from the Medical Device Alliance) led to discussions on a wide range of medical device development topics.  Passers by gravitated to our route map for medical technology development, with many printed copies leaving in people’s bags.

Many people chose to enter a draw to win a printed copy of our book introducing Human Factors for medical devices “How Humans Factor (in medical device design)”.

Congratulations to the two winners in our prize draw, who will each receive their book in the post over the next few days.

And yes, the team’s preparations are already underway for next year’s Innovation Day.