The New MDR - Is It Really New and Do We Really Need It - Greenlight Guru - March 2021

The “New” EU Medical Device Regulation (MDR):
Is it really new and do we really need it?
Presented by:
Michael Drues, Ph.D.

President, Vascular Sciences
Carlsbad, California
and
Adjunct Professor of Regulatory Science, Medicine

and Biomedical Engineering
George Washington University Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
GreenLight.Guru (March 19, 2021)
For questions or more information, call

(508) 887 – 9486 or e-mail mdrues@vascularsci.com
© Copyright 2021 by Vascular Sciences and Michael Drues, Ph.D. All rights reserved.
presented by: Michael Drues, Ph.D.
There is much reportedly changing in the EU medical device regulatory system but why is the system changing? And is the
system really changing or is this another example of the more things change the more they remain the same? Ironically,
medical devices are required to be tested and validated prior to market. Should not the same apply to new regulation, i.e.,
the EU “new” MDR system?
In this presentation, Dr. Drues discusses the most significant changes in the EU Medical Device Regulation (MDR) system,
why these changes are being made, and most importantly provides a critical analysis of whether or not these changes will
likely do any good – a question few in this industry seem to be asking. Questions to be discussed include:
• What are the most significant changes in EU MDR system, i.e., what are the changes that really matter?
• Why is the EU MDR system changing and why now?
• What is the root cause(s) i.e., precipitating event(s) leading to these changes?
• What are changes in substance vs. changes in paperwork?
• Has the new MDR system been “validated” prior to releasing to the market?
• Will these changes lead to safer and more effective medical devices in the future? What if they don’t?
• Why aren’t more people asking these same questions?
Simply put: years from now, will these changes lead to safer and more effective medical devices in the future? What if
they don’t? And if we don’t see fewer problems with medical devices in the future, aren’t all these changes just a colossal
waste of time and money?
What to know more?

For more, visit Global Medical Device Podcast (GreenLight.Guru) here, Mike on MedTech (Medical Product
Outsourcing) here, Medical Design and Outsourcing here, Guerilla Regulatory Strategy (MED Device
Online) here and Healthcare Packaging here or LinkedIn here.
Speaker Biography
Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, &
consulting company offering a broad range of services to medical device,
pharmaceutical & biotechnology companies including stimulating & innovative
educational programing, creative regulatory strategy & completive regulatory
intelligence, regulatory submission design, FDA presentation preparation & defense,
brain-storming sessions, prototype design, product development, benchtop & animal
testing, , clinical trial design, reimbursement, clinical acceptance, business
development & technology assessment.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from
Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and
biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for
the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare
and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and
regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology
companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US
Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
For additional information, contact Dr. Drues directly at (508) 887-9486, e-mail mdrues@vascularsci.com
or via LinkedIn at www.linkedin.com/in/michaeldrues.
© Copyright 2021 by Michael Drues and Vascular Sciences. All rights reserved.

presented by:
Michael Drues, Ph.D.

President, Vascular Sciences, Carlsbad, California
and
Adjunct Professor of Regulatory Science, Medicine and Biomedical Engineering
George Washington University Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
For questions or more information, contact me at

(508) 887 – 9486 or mdrues@vascularsci.com
Join me on LinkedIn at www.linkedin.com
The “New” EU Medical Device Regulation (MDR): Vascular Sciences © Copyright 2021 by Michael Drues, Ph.D.
Is it really new and do we really need it? 1 and Vascular Sciences. All rights reserved.
Do you want more?
Global Med Dev Podcast (GreenLight.Guru) here

Mike on MedTech (Medical Product Outsourcing) here
Medical Design and Outsourcing here
Guerilla Regulatory Strategy (MED Device Online) here
Healthcare Packaging here
LinkedIn here
For columns, articles and podcasts… visit www.VascularSci.com

2
GreenLight.Guru Webinar (March 19, 2021)
www.greenlight.guru
For additional information, www.linkedin.com/in/michaeldrues, Taken from: Designing Medical Products Seminar Serie
call (508) 887-9486 or e-mail mdrues@vascularsci.com 1 Copyright 2021, Michael Drues, Ph.D
Here’s what we’ll talk about…
✓ What are the most significant changes in EU MDR system, i.e., what are the
changes that really matter?
✓ Why is the EU MDR system changing and why now?
✓ What is the root cause(s) i.e., precipitating event(s) leading to these
changes?
✓ What are changes in substance vs. changes in paperwork?
✓ Has the new MDR system been “validated” prior to releasing to the market?
✓ Will these changes lead to safer and more effective medical devices in the
future? What if they don’t?
✓ Why aren’t more people asking these same questions?
✓ Lots more tips and tricks… time permitting!
✓ Final thoughts…
Why do we need a
“New” MDR… or do we
Simply put…
The system is not perfect!
4
www.greenlight.guru
Public Perception
Article: New Documentary Film Is Scathing Indictment Of FDA's Regulation Of Medical Devices (Forbes, July 29, 2018) here or attached
Video: The Bleeding Edge Trailer on Netflix or YouTube
Video: We are guinea pigs: Filmmakers on the risks of medical devices (CBS News, July 27, 2018) on CBS or YouTube
Implant Files
Implant Files Video: here Home Page here.

The regulatory ancestral network of surgical meshes here.
6
www.greenlight.guru
Is more regulation a
good thing
“The new [MDR] regulation has a word count that is nearly

four times higher than its predecessor, the Medical Devices
Directive (MDD), contains five more annexes, and uses the
word “safety” 290 times, rather than just 40 times.”
Seeking A Smooth Transition To The New EU MDR? (MED Device Online, June, 2017) here
Do you need to know anything else?

Does more words mean safer and more effective products?
What's the relationship between regulation and innovation?
How much regulation is enough?
Between 2000–2012 → average increase of 11,920 words/year (increased by 15%) in the CFR
Changes reflect requirements for drugs, devices, biologics, foods, and tobacco products
To put the increase into perspective, the 166,892-word increase is longer than Tolkien's “The
Hobbit” (95,356 words), Dickens' “Oliver Twist” (155,960 words) and just barely shorter than
Steinbeck's “The Grapes of Wrath” (169,481 words).
It's Not Just You: FDA Regulatory Requirements Really Are Increasing (RAPS, Oct. 30, 2014) available here.
So with all this regulation,
Are our products really any safer and more effective? …is the world a better place?
8
www.greenlight.guru
How does the “new”

MDR compare to
regulatory and quality
requirements in the US?
In other words…
Are the two systems converging or diverging?

Is this a good thing or a bad thing?
Clinical Evidence
Pre-Market Clinical Data
• MDR clinical evidence requirements have been increased – or have they?

• Historically based on device equivalence to mitigate/eliminate clinical burden
• Less moving forward (especially for high risk devices) but definitely still possible
• Expect to be challenged by notified body – as you should be!
• Must show same/similar engineering / biological / clinical (usability) characteristics
• Risk management files and clinical evaluations should be integrated not isolated
• Manufacturer needs to have access to the comparator’s data (i.e., tech file and risk
analysis). Competitors are unlikely to share this type of data so what do we do?
• To acquire required data, additional clinical studies may be needed (MedDev 2.7.1R4, ’16)
• What will be the role of Real World Evidence / Real World Data in the EU?
10
www.greenlight.guru
Clinical Evidence
Post-Market Clinical Data
• Post-market surveillance (PMS) requirements incorporated into MDR – why?

• PMS for Class II/III devices including post-market clinical follow-up (PMCF) and
periodic safety update reports (PSUR)
• Class I manufacturers need to maintain PMS Reports – necessary but less critical
• Reduction in time required for notification of Competent Authorities of serious
adverse events — from 30→15 days – should it be less? What about product
liability?
• Integrate regulatory and quality (i.e., medical device reporting, complaint handling,
CAPA, etc.
11
How will medical device

classification be changing
More importantly…
Or will it?
Principles of classification are timeless!
Jean-Baptiste Alphonse Karr (1808–1890) said
“The more things change, the more they stay the same.”
12
www.greenlight.guru
How is classification changing

in the EU?
• Classification rules (Annex VIII) have been expanded but still based on existing principles:
• Duration of patient contact
• Transient (<60min), continuous (>60min→<30days) or long term (>30days)
• Degree of invasiveness, i.e., noninvasive, invasive via body orifice or surgically invasive
• Operative mode of action, i.e., passive or active (source of power not gravity or human body)
• Effect on body, i.e.,

• local – limited to area where device is applied [Question: Does any device really act locally?] or
• systemic – effects of device may be outside area of application
Reality is much more complicated – regulatory logic is key!
• Devices previously considered borderline/outside MDD may now be regulated med devices
• MDR now applies to some devices without an “intended medical purpose” (Annex XVI)
• Classification of existing devices may be changing (↑ or ↓) – manuf responsibility to monitor
• New classification rules → aligning US/EU system – will we have harmonized classification?
13
Classification in US
Classification depends on 3 things:
• High-level labeling
• Risk [many connotations!]
• Probability of direct harm
• Probability of harm from
not using
• Probability of providing the
wrong info
Not nearly so simple!
Example: What class is a scalpel?

Short answer: it depends!
intended use → cut tissue → class I
intended use → corneal incision → class III
indications for use found in labeling but…
may also be conveyed orally during sale of
product so…
Should you put this ‘use’ on your label? CDRH Website (April, 2014) [here]
14
www.greenlight.guru
EU Classification System – Correcting Past Mistakes
Are all non-invasive devices ‘low risk’?

Examples: AED? IVD for cancer? ColoGuard?
Is it really so simple?
Absolutely not – this is why the ‘regulatory logic’ is most important!
15
Is this what we really want?

How do I
determine
classification
in the EU?
What does final

classification
estimate mean?
available here.
16
www.greenlight.guru
Top 10 Changes (Challenges?) in the “New” MDR
1. Updated Classification / Reclassification Requirements (still based on risk – in part!)
2. New “CE” Mark (2017/745)
3. Legacy Products
4. Reprocessing (Reusable and Single Use Devices)
5. More robust Technical Documentation (Regulatory and Quality)
6. Clinical Evidence
❖ pre-market vs. post-market surveillance (now rule rather than exception!)
❖ proportional to risk but don’t stop there!
7. Mandatory Product Liability Insurance (this should be a business decision!)
8. Transparency (enhanced EUDAMED database)
9. Labeling and Supply Chain
❖ person responsible for regulatory compliance (PRRC) and EU Authorized Rep (EUAR)
❖ More comprehensive labeling requirements
10. Unique Device Identification (UDI) system (details TBD but similar to US?)
Bottom Line:
“New” MDR will impact virtually all areas of device development → manuf should proactive but…
May not be as burdensome as many think! [consider international regulatory/quality strategy]
Adopted from Top 10 Challenges of the New MDR (MPO, June, 2017) here
17
Customer Question
In the US, a predicate device can be a competitor’s device but the only
information you will have is going to be what you can gather on the
Internet. In Europe, with the new MDR, utilization of a “similar” device is
going to require access to technical design and performance
specifications. So unless your competition is willing to share these details,
your similar device is going to have to be a device already in your product
portfolio. This may not be a problem for companies with devices already on
the market. However, it will make it very difficult, if not impossible, for start-
up companies with novel technology to gain EU approval. So what do we
do?
18
www.greenlight.guru
What does the future hold?
Areas under addressed or not addressed in “new” MDR:

✓ Root cause… treating symptoms vs. underlying cause
✓ Regulation that is reactive vs. proactive
✓ Human factors / Usability
✓ Use of Real World Evidence… RWE vs. RWD
✓ Personalized Medicine, i.e., 3DP – clearly the future of medicine!
✓ Combination Products including Companion Diagnostics and beyond!
✓ Wellness Devices – remains a regulatory grey area
✓ Communication i.e., pre-sub and other methods – root cause of most problems!
✓ Etc., etc.
Bottom line:
“New” MDR is a big step but just another step… much more work needs to be done!
19
Here’s what we’ll talk about…
✓ What are the most significant changes in EU MDR system, i.e., what are the
changes that really matter?
✓ Why is the EU MDR system changing and why now?
✓ What is the root cause(s) i.e., precipitating event(s) leading to these
changes?
✓ What are changes in substance vs. changes in paperwork?
✓ Has the new MDR system been “validated” prior to releasing to the market?
✓ Will these changes lead to safer and more effective medical devices in the
future? What if they don’t?
✓ Why aren’t more people asking these same questions?
✓ Lots more tips and tricks… time permitting!
✓ Final thoughts…
20
www.greenlight.guru
There are many regulatory consultants out there…
but there are surprisingly few good ones!
So how do you become a good one?
Learn when to follow and

more importantly…
when to lead!
21
Don’t just follow the

rules… think!
Rules are mostly made to be broken

and are too often for the lazy to hide behind.
General Douglas MacArthur (1880 –1964) was an American general in the US Army during the
1930s and played a prominent role in the Pacific theater during World War II. He was one of only
five men ever to rise to the rank of General of the Army in the U.S.
22
www.greenlight.guru
“Imagination is more
important than
knowledge, for while
knowledge points to all
there is, imagination
points to all that can be.”
Albert Einstein
“Logic will get you from

A to B. Imagination will
take you anywhere.”
Albert Einstein
23

www.greenlight.guru

The New MDR - Is It Really New and Do We Really Need It - Greenlight Guru - March 2021

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

The New MDR - Is It Really New and Do We Really Need It - Greenlight Guru - March 2021

Uploaded by

Copyright:

Available Formats

The “New” EU Medical Device Regulation (MDR):

Is it really new and do we really need it?

Michael Drues, Ph.D.

Adjunct Professor of Regulatory Science, Medicine

GreenLight.Guru (March 19, 2021)

For questions or more information, call

What to know more?

The “New” EU Medical Device Regulation (MDR):

Michael Drues, Ph.D.

For questions or more information, contact me at

Do you want more?

Global Med Dev Podcast (GreenLight.Guru) here

For columns, articles and podcasts… visit www.VascularSci.com

Here’s what we’ll talk about…

The system is not perfect!

Implant Files Video: here Home Page here.

“The new [MDR] regulation has a word count that is nearly

Do you need to know anything else?

How much regulation is enough?

How does the “new”

Are the two systems converging or diverging?

Pre-Market Clinical Data

• MDR clinical evidence requirements have been increased – or have they?

Post-Market Clinical Data

• Post-market surveillance (PMS) requirements incorporated into MDR – why?

How will medical device

Jean-Baptiste Alphonse Karr (1808–1890) said

How is classification changing

• Effect on body, i.e.,

Example: What class is a scalpel?

Are all non-invasive devices ‘low risk’?

Is this what we really want?

What does final

What does the future hold?

Areas under addressed or not addressed in “new” MDR:

Here’s what we’ll talk about…

Learn when to follow and

Don’t just follow the

Rules are mostly made to be broken

“Logic will get you from

GreenLight.Guru Webinar (March 19, 2021)

You might also like