Regulatory Open Forum

Can anyone inform what type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR?

Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices, or do we need to submit clinical trial data if MDR requires clinical trial?

Background: There is a legacy device with CE marking under MDD, and we are planning to convert to MDR by May 2024 when the certification becomes void. As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial?

Dear Lauren,

avoiding clinical trials with legacy devices in the scope of MDR transition is a very important aspect for many manufacturers.
Therefore it is of utmost importance to use the time under your valid MDD certificate to create sufficient data that can be used to transfer your device to the MDR (if you dont already have enough).

How can you do that?
The MDR requires you to conduct post-market clinical follow-up activities. Implement them already under your MDD certificates, using a MDR compliant process. Create data, if necessary, e.g. by PMCF studies (considering ISO 14155) or other measaures.

I also recommend to review your existing clinical evaluation report. How much of your data can you use under the MDR? The MDR is more strict regarding what data you can include than the MDD/MEDDEV. Based on the results of assessing the clinical data with focus on MDR compliance, think of creating additional data as mentioned before.

There´s also a guidance available regarding nedded clinical evidence for legacy devices: https://ec.europa.eu/docsroom/documents/40904

Kind regards
Lukas

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany
------------------------------

Original Message:
Sent: 02-Aug-2020 18:52
From: Lauren Kim
Subject: Requirement for legacy MDD device to MDR in May 2024

Can anyone inform what type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR?

Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices, or do we need to submit clinical trial data if MDR requires clinical trial?

Background: There is a legacy device with CE marking under MDD, and we are planning to convert to MDR by May 2024 when the certification becomes void. As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial?

Dear Lukas,
Agreed!

Dear Lauren,
The relevant article is here:
Article 61
...
6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:
(a) which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
- is based on sufficient clinical data, and
- is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available; or
...

The only grandfathering clause in the regulation. The guidance on sufficient is important.  However, if the clinical data have been sufficient under the MDD then it should be sufficient under the MDR.  Otherwise the clinical data in your DD are not sufficient today under the MDD and could reflect on the NB.  You may have to adjust to new formats and make sure the PMCF is solid.

And this goes along nicely with conformity assessment procedure under Article 54:
...
2. The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
(a) in the case of renewal of a certificate issued under this Regulation;
(b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device;

And it was clarified that (b) refers to MDD products. See MDCG 2019-3 Rev.1 Interpretation of Article 54(2)b
https://ec.europa.eu/docsroom/documents/40661

Without knowing the details, the above must have been applied with the very first class III certification, which was done and promoted by TUV SÜD.

Please let me know whether the above is helpful or if you have any other information supporting that your clinical data today are OK for the MDR tomorrow..

------------------------------
Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
------------------------------

Original Message:
Sent: 03-Aug-2020 01:26
From: Lukas Losigkeit
Subject: Requirement for legacy MDD device to MDR in May 2024

Dear Lauren,

avoiding clinical trials with legacy devices in the scope of MDR transition is a very important aspect for many manufacturers.
Therefore it is of utmost importance to use the time under your valid MDD certificate to create sufficient data that can be used to transfer your device to the MDR (if you dont already have enough).

How can you do that?
The MDR requires you to conduct post-market clinical follow-up activities. Implement them already under your MDD certificates, using a MDR compliant process. Create data, if necessary, e.g. by PMCF studies (considering ISO 14155) or other measaures.

I also recommend to review your existing clinical evaluation report. How much of your data can you use under the MDR? The MDR is more strict regarding what data you can include than the MDD/MEDDEV. Based on the results of assessing the clinical data with focus on MDR compliance, think of creating additional data as mentioned before.

There´s also a guidance available regarding nedded clinical evidence for legacy devices: https://ec.europa.eu/docsroom/documents/40904

Kind regards
Lukas

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany

Original Message:
Sent: 02-Aug-2020 18:52
From: Lauren Kim
Subject: Requirement for legacy MDD device to MDR in May 2024

Can anyone inform what type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR?

Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices, or do we need to submit clinical trial data if MDR requires clinical trial?

Background: There is a legacy device with CE marking under MDD, and we are planning to convert to MDR by May 2024 when the certification becomes void. As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial?

In general, you need a complete technical documentation as required for a "new MDR device" also for your legacy device.

------------------------------
Lukas Losigkeit
CEO & Principal Consultant
Hamburg
Germany
------------------------------

Original Message:
Sent: 02-Aug-2020 18:52
From: Lauren Kim
Subject: Requirement for legacy MDD device to MDR in May 2024

Can anyone inform what type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR?

Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices, or do we need to submit clinical trial data if MDR requires clinical trial?

Background: There is a legacy device with CE marking under MDD, and we are planning to convert to MDR by May 2024 when the certification becomes void. As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial?

Hello Lauren,

That is a fairly broad question because there are number of documents you may need or would be required to support clinical evaluation of a Class III device certified under the EU MDD 93/42/EEC - planning to transition to the EU MDR.  Probably the most important section you can read is in Article 61 subpoint 6 saying 'The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and Class III devices: (a) which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:

- is based on sufficient clinical data
- is in compliance with the relevant product-specific CS for the clinical evaluation ...'

Added a little emphasis so sufficient clinical data needs to be available for your legacy MDD Class III device which may include many different clinical sources include postmarket data, design changes, clinical literature, and Post Market Clinical Follow-up (PMCF).  All of these will need to be determined for your legacy MDD device - providing a couple points of advice.

1. Re-do, revise, re-vamp, etc. your current clinical evaluation from a completely "new" perspective.  There is no grandfathering with the EU MDR so treat everything as new, and look at the clinical evaluation from the EU MDR perspective.  Just do not try to fill the gaps.
2. If you are concerned about having sufficient clinical data and maybe need for a PMCF, start some discussions with your NB now.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 02-Aug-2020 18:52
From: Lauren Kim
Subject: Requirement for legacy MDD device to MDR in May 2024

Can anyone inform what type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR?

Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices, or do we need to submit clinical trial data if MDR requires clinical trial?

Background: There is a legacy device with CE marking under MDD, and we are planning to convert to MDR by May 2024 when the certification becomes void. As per the MDR requirement, this device needs clinical trial if it is a new certification, but can we avoid this situation by utilizing the post market data and not conducting the clinical trial?