Article 61 (6) &

MDCG 2020-6
Clinical Masterclass - Well Established Technologies

Richard Holborow
Head of Clinical Compliance
January 2022

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Poll Question

Do you consider yourself a manufacturer of a Well-Established

Technology?

• Yes
• No

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Topics Covered in this presentation;

❑ What is meant by the term ‘WET’? (Article 52 (5))

❑ What devices can be considered WET according to
the MDR?
❑ MDCG 2020-6 & the term ‘WET’
❑ 4 Criteria of WET from MDCG 2020-6
❑ MDCG 2020-6 Key Messages
❑ When to consider sufficient levels of evidence?
❑ Questions

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Poll Question

Do you agree with the following statement –

Any legacy device be considered a WET because it has

been previously marketed.

a.Agree
b.Disagree

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A certain group of devices…(Article 52)

Article 52 (4) of the MDR allows

for a certain group of Class IIb
implantable devices to be
‘sampled’ through the certificate
cycle.

This group of class IIb implantable devices are permitted to allow for
technical sampling’ through the certificate cycle because they are low risk
implantable devices with an established safety and performance profile
for their generic device group.

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Well Established Technologies

These are the devices that are specifically called out within the MDR text as
‘Well Established Technologies’

Article 52 (4) describes these technologies as class IIb implantable.

Article 52 (5) of the MDR makes it clear how other devices can be added to
this list.

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Article 52 (5)

Article 52 (5)
refers to this
certain group of
devices as ‘well
established
technologies’
The MDR is clear that the conformity assessment route for this group of class IIb
devices cannot be changed unless by a delegated act in accordance to Article 115.

A delegated act means that the European Parliament must approve this change.

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What does this have to do
with Clinical Evaluation
and Clinical Evidence?

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MDR Article 61 (6) This paragraph within Article 61 is related
to types of Class III and Implantable
devices that do not require clinical
investigations
Clause (a) allows for
class III /Implantable
legacy devices not to
perform clinical
investigations and to
move to MDR - but
should have sufficient
clinical data

Clause (b) lists a group of devices but how do we

know these are Well Established
Technologies(WET) as referred to in Article 52 (5) ?

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Article 61 (8) Here is the term ‘WET’ again and provides the legal
link to those devices we have just seen in Article 61
(6) (b)

That list can only be

amended by a This confirms that WET
delegated Act i.e. that Article 52 (4) refers to the can be class III or
is a new law and not conformity assessment Implantable
guidance. route for WET – this was
on slide 5

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So….
According to the MDR it is clear that a new device never previously marketed
under Directives can be considered a Well Established Technology if;

• It is sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips
and connectors.* and
• is Class III or Implantable

*This list can only change if the MDCG release a delegated Act i.e. a new law amending the list.

Ok, well what about

legacy devices? What is
classed as a WET for
legacy devices?

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MDCG 2020-6
• This guidance was created to look at
sufficiency of data for legacy devices.

• The MDCG group wanted to ensure

that ‘standard of care’ devices
would be allowed entry under the
MDR.
This document also
• Obvious but Important point: This mentions the term ‘Well
Established Technology’.
guidance was created for legacy But does this have the
devices certified under MDD/AIMDD meaning as we see in the
MDR text?

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So what does the guidance say about W.E.T?
‘well-established technology’: this terminology is used in Article 52(5) and Article 61(8) of the MDR, but is not
defined in these articles. The term is not restricted to the devices listed in Article 61(6b); Article 61(8) explicitly
states that this includes devices similar to the exempted devices listed in Article 61(6b), which might be added to
that list in future.
The common features of the devices which are well established technologies are that they all have:
• relatively simple, common and stable designs with little evolution;
• their generic device group has well-known safety and has not been associated with safety issues in the past;
• well-known clinical performance characteristics and their generic device group are standard of care devices
where there is little evolution in indications and the state of the art;
• a long history on the market.
Therefore, any devices that meet all these criteria may be considered “well established technologies”.

These 4 bullet points need to be considered to

demonstrate that they are a standard of care
device.

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 Well Established Technology _

The interpretation of WET from MDCG 2020-6 is trying to align with article 61 (6) (a) that for legacy
devices sufficent evidence is required and that it may be acceptable that these ‘standard of care devices’
may have lower levels of evidence if they meet the 4 criteria mentioned previously.

The MDR has to take precedence and the list of WET as mentioned in Article 61 (6) (b) cannot
be changed unless by an implement act according to article 115.

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MDCG 2020-6: “Sufficient clinical evidence” for legacy devices

Appendix III of MDCG

2020-6 provides a
suggested hierarchy of
clinical evidence for legacy
devices.

But is this really new The level of evidence may

be less for standard of care
information or different from devices that meet the four
criteria points as defined in
the MDR? this guidance

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MDR Article 61 (6)

Remember this point

that exempts Class
III and Implantable
legacy devices from
clinical
investigations?

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 Class III and
Full Circle…Principles of Clinical Evaluation Implantable Legacy
devices that are
‘Standard of care
devices’ maybe exempt
from performing a
clinical investigation if it
can be demonstrated
that sufficient levels of
data exist, the
manufacturer should
justify what evidence
they have to support
conformity to the GSPRs.

We should look at the data presented for a legacy device and ask is it sufficient for
the device under evaluation and not be too concerned about whether it is WET
according to MDCG 2020-6
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The four criteria in MDCG 2020-6 can be helpful to determine the
characteristics of what can be considered a ‘standard of care’
device:

• relatively simple, common and stable designs with little evolution;

• their generic device group has well-known safety and has not been associated with safety issues
in the past;

• well-known clinical performance characteristics and their generic device group are standard of
care devices where there is little evolution in indications and the state of the art;

• a long history on the market.

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Point 1 - relatively simple, common and stable designs with little
evolution;
Simple, Common and Stable Designs –

Simple designs should be considered as uncomplicated well known designs with commonly used materials.

Devices that involve additional supporting medical equipment or have specific medicinal or animal tissue properties
may not be considered simple.

Commonly used designs could be evident from SoTA literature searches of generic device groups– if the device has
novel aspects these may be unacceptable.

Small changes to improve usability could be acceptable. However significant design developments that change how
the device is used or functions may not be acceptable.

Little Evolution –
This should consider not only design developments but also consider any developments to other devices in the
generic device group.

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Point 2 - their generic device group has well-known safety and
has not been associated with safety issues in the past;
This could be evidenced by post market surveillance
history of the device itself and coupled with known
state of the art risk profile for these groups of
devices.

MAUDE database searches can also demonstrate the

safety profile of the generic device group.

Consider any evidence that the generic device groups

have not identified any new residual risks.

Devices that have had Field Safety Notices (FSN)

issued in relation to the devices safety or
performance may not be able to demonstrate and
meet this point.

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Point 3 - well-known clinical performance characteristics and
their generic device group are standard of care devices where
there is little evolution in indications and the state of the art;
‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of
technology allowing them to be classified in a generic manner not reflecting specific characteristics; (Article 2 (7))

• Manufacturers should demonstrate that their device aligns in relation to safety and performance profile
against other devices from that generic group.

• Recommendations of the device or generic device group from medical society or national guidance
boards such as NICE can be supportive evidence to demonstrate this point.

• Devices that have changed or unique indications to other generic device groups may not be suitable.

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Point 4 - A long history on the market.
What is the claimed lifetime
of the device?
Is there extensive
When was the device first
experience of the same
CE Marked? Has the device achieved its
users of the device?
claimed lifetime?

The market – What markets

Does this long history
Have the indications has the device been placed
demonstrate that no new
remained the same through on? Are there new EU
residual risks have been
this period? locations? Is there other
identified with the device
geographical data to
over recent years?
support its long history?

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Poll Question

Can a standard of care legacy device rely solely on complaint &

vigilance Data?

a. Yes
b. No

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What can be considered sufficient clinical data for a
legacy device?

MDCG 2020-6 Appendix III provides a helpful list

to consider types of data that can be used to
support a legacy device.

In line with Article 61 (1) of the MDR:

The manufacturer shall specify and justify the level of
clinical evidence necessary to demonstrate conformity
with the relevant general safety and performance
requirements. That level of clinical evidence shall be
appropriate in view of the characteristics of the device
and its intended purpose.

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MDCG 2020-6: “Sufficient clinical evidence” for legacy devices

Key reinforced concepts

• Clinical data generation and evaluation is an ongoing lifecycle process

• Benefit-risk conclusions must be based on consideration of outcomes achievable with other available
treatment options

• Benefit-risk conclusions must be based on “sufficient clinical evidence”, including PMS data

• The “level of clinical evidence” must be specified and justified by the manufacturer, taking device
characteristics and intended purpose into account

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MDCG 2020-6: “Sufficient clinical evidence” for legacy devices

Key reinforced concepts

Condensing down page 9:
• Devices previously certified under the Directives might not have “sufficient clinical evidence” under the
MDR
• But really, they should have, because they would have been placed on the market on the basis of
sufficient clinical data, and they should have been gathering additional clinical evidence as requirements
and guidance developed over time
• The clinical evidence used for the initial certification plus data gained from PMS and PMCF will be the
basis of MDR applications

But what about the legacy ‘Standard of Care’ that may have been placed
on the market with little or no clinical evidence, and which are so well-
established that little or no clinical evidence was considered to be
required?

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MDCG 2020-6: “Sufficient clinical evidence” for legacy devices

Key reinforced concepts

Condensing down page 9 (continued):
• Under the Directives, NBs should have required PMCF for devices certified on the basis of equivalence*
• As part of the MDR conformity assessment, NBs should ensure PMCF studies have been undertaken as
required under the Directives, and the results incorporated into the manufacturer’s clinical evaluation**

* “MEDDEV 2.12/2 regarding PMCF also notes that in the case that
clinical evaluation was based exclusively on clinical data from equivalent
devices for initial conformity assessment, the certifying notified body
shall verify that PMCF studies have been conducted”

** “When assessing the conformity of legacy devices under the MDR, it

is important to verify whether PMCF studies considered necessary under
the MDD/AIMDD (and where applicable, during the transition period,
under the MDR), have been appropriately conducted, and results are
taken fully into account for in the clinical evaluation for the conformity
assessment under MDR.”
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Rank #1 of MDCG 2020-6
This is the ideal level of evidence that
would be expected for devices.

This aligns with the MDR

requirements for new Class III and
implantable devices.

It is known that perhaps older

historical devices may not have any
data from clinical investigations.

There is also acceptance that clinical

investigations may not be practical for
some types of devices.

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Rank #2 of MDCG 2020-6
Any gaps in clinical investigations
will need to be justified or other
evidence provided.

We do commonly see lack of

evidence to support ALL
indications.

It can be expected that some

indications may have less levels of
evidence than others - for example.
because it is not as frequently used
for that clinical indication.

If this is the case the manufacturer

should always justify the level of
evidence for each of the indications

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 This does not specify whether these are
Rank #3 of MDCG 2020-6 national registries or manufacturer
registries of data. Both could be
acceptable.

National Registries are common for

some implantable devices and use of
this data could be acceptable. Registries
outside of the EU can be supportive but
consideration should be given to
geographical differences such as clinical
practice, patient physiology etc.

Considerations include:
- Can all device variants/indications be identified from this data?
- Comparative data from national/international registries can be supportive to demonstrate state of the art
and show that your device aligns to the generic device group.
- Registry data should consider patient outcomes and not market share.

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Rank #4 of MDCG 2020-6
Data reported form literature on the
device under evaluation can be
supportive. Note the comment
around no safety or performance
concerns identified.

High Quality Surveys – We are seeing many manufacturers approach this method. It has any advantages of
being able to get data quickly. A high quality survey should focus on clinical outcomes, indications of which
the device has been used and ideally be prospective in its data collection.
Retrospective surveys do have limitations.
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Levels 1-4 Statement This statement within
Appendix III is important. The
message is clear that there is
an expectation that Class III
and implantable devices have
‘high quality clinical data’

The term ‘should have’ is there because this is guidance and not legally binding.

There will be some class III devices/Implantable devices where it is impractical to have data
levels 1-4 e.g. devices to support an implant, implanted accessories.

The manufacturer should specify and strongly justify the level of evidence if they believe these
circumstances apply.

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Rank #5 of MDCG 2020-6
There is an expectation that any
devices that claimed equivalence
under the MDD should have had
appropriate PMCF in place during this
time to generate data on their own
device.

The regulatory requirements of

equivalence must meet the tighter
stringent criteria of the MDR if
equivalence is claimed.

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Rank #6 of MDCG 2020-6 All clinical evaluations should
perform a state of the art
assessment.

For those groups of devices defined

as WET in Article 61 (6) b this can
be supportive to demonstrate
alignment with the generic device
group.

Generally state of the art alone or

coupled with PMS and vigilance is
not usually sufficient. This guidance
suggests that there should be
cumulative evidence from
additional sources.

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Rank #7 of MDCG 2020-6 The guidance does state that
compliant and vigilance alone
is not sufficient.

All legacy devices should

present this data with other
sources. If the device has
been marketed then this data
will exist.

This data can also be helpful

in demonstrating alignment
with other generic device
groups.

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Rank #8 of MDCG 2020-6 Proactive PMS data is helpful to
confirm or identify existence of any
safety concerns or performance
issues.

Note: Surveys are mentioned here

again, this is assumed to be lower
quality surveys compared to those
mentioned in rank #4

Examples of lower quality surveys

include:
• Retrospective surveys
• End user surveys focused on
experience of device
• Low return rates
• Not focused on PROMS
• Limited to address small gaps in
data

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Rank #9 of MDCG 2020-6
Individual Case Reports could
be supportive in retaining
indications where the device is
rarely used.

Case reports may also be

helpful to support lower risk
devices where larger clinical
investigations are impractical
or not feasible.

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Rank #10 of MDCG 2020-6
At this point of the hierarchy we
start to see the introduction and
acceptability of pre-clinical data.

We are yet to see common

specifications published by the
EU Commission in relation to
clinical evaluation.

However any CS that address

clinically relevant endpoints
through non-clinical evidence
should be presented to support
the conformity assessment.

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Rank #11 of MDCG 2020-6
This aligns with Rank #10 of
the hierarchy. This is not clinical
data but for certain devices can
be used as cumulative evidence
to conform to the relevant
GSPRs

If this evidence is ever used then some

follow up PMCF or proactive PMS may be
required to confirm any claims or to
substantiate the evidence provided.

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Rank #12 of MDCG 2020-6
Again aligning with Ranks #10
and #11.

Not considered clinical data.

Devices that rely on pre-clinical

data will typically need to
consider some PMCF activities to
gather clinical data to support
these claims.

For some devices where pre-clinical data is appropriate they should consider Article 61 (10) to
see if this is relevant and may be an easier route to conformity.

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Tell the Story…
Article 61 (1): The manufacturer shall specify and justify the level of
clinical evidence necessary to demonstrate conformity with the relevant
general safety and performance requirements. That level of clinical
evidence shall be appropriate in view of the characteristics of the
device and its intended purpose.

• Describe why the evidence you hold can be considered sufficient

and why this evidence can meet the relevant GSPR.

• Describe why that evidence you hold is appropriate given the

devices intended purposes and characteristics of the device.

• If there are gaps or flaws in your evidence then be transparent

about this and describe how you plan to address these.

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BSI Medical Devices – Use Our Resources
https://www.bsigroup.com/en-GB/medical-devices/resources

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We have more webinars available in our Clinical Masterclass series.

The next webinar available is:

2nd February 2022 - Understanding Article 61 (10) – When Clinical Data is not deemed
appropriate

Use the link to sign up to this webinar and any other webinar(s) in the series:

https://www.bsigroup.com/en-GB/medical-devices/resources/webinars/2022/mdr/clinical-
masterclass/

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Questions?

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