Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
I am trying to get some opinions on approaches to addressing SPR 10.4. Our devices are metallic permanent implants.
Our consultant has suggested performing extraction testing, to see what could possibly come off the device, but there is debate if this is sufficient. 

First of all there are lots of lists of these CMR substances, hazardous substances, suspect substances that are part of Regulation 1272/2008 and 1907/2006.  You can use other resources also such as the REACH Regulation of RoHS Regulation, though these might not be too appropriate to a metallic-based implant.  There are other lists out there for metal materials that can be referenced.  You should also work with your supplier to understand processing of this metal, how its made, where it comes from, purity, etc., because you may have sufficient information from the supplier to support hazardous substances through leaching or absorption.  It also depends on how you are processing the metal in your own processes that may introduce other substances needing to be accounted for.  Follow the intent of ISO 10993-1 to characterise your product, components, and raw materials.

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

Original Message:
Sent: 20-Jun-2019 08:16
From: Anonymous Member
Subject: EU MDR SPR 10.4 - Hazardous Substances

This message was posted by a user wishing to remain anonymous

Hello,
I am trying to get some opinions on approaches to addressing SPR 10.4. Our devices are metallic permanent implants.
Our consultant has suggested performing extraction testing, to see what could possibly come off the device, but there is debate if this is sufficient. 

Design and manufacture of devices

Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by

substances or particles, including wear debris, degradation products and processing residues, that may be

released from the device.

Devices, or those parts thereof or those materials used therein that:

- are invasive and come into direct contact with the human body,

- (re)administer medicines, body liquids or other substances, including gases, to/from the body, or

- transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the

body, shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w)

where justified pursuant to Section 10.4.2:

(a) substances which are carcinogenic, mutagenic or toxic to reproduction ('CMR'), of category 1A or 1B, in

accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of

the Council (1), or

(b) substances having endocrine-disrupting properties for which there is scientific evidence of probable serious

effects to human health and which are identified either in accordance with the procedure set out in

Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once

a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of

Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the

criteria that are relevant to human health amongst the criteria established therein.

In my opinion, extraction testing is not sufficient.

The requirement in the first paragraph of 10.4.1 is to reduce the risk from three sources: wear debris, degradation products, and processing residues.

For wear debris, I would expect an accelerated test of wear for the lifetime of the device. The test would capture any wear debris and analyze it.

Similarly you would need to model any degradation processes, collect the products, and analyze them.

Similarly you would need to characterize your production processes for any residue.

Since your device is invasive and comes into direct contact with the human body you will to determine the composition to see if it exceeds the concentration of 0.1% weight by weight of the substances identified in 10.4.1(a) and 10.4.1(b). If so, then you will need to follow 10.4.2.

For now, you should determine any members of the ISO 10993 family that cover these situations. One day there will be harmonized standards that provide the information.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 20-Jun-2019 08:16
From: Anonymous Member
Subject: EU MDR SPR 10.4 - Hazardous Substances

This message was posted by a user wishing to remain anonymous

Hello,
I am trying to get some opinions on approaches to addressing SPR 10.4. Our devices are metallic permanent implants.
Our consultant has suggested performing extraction testing, to see what could possibly come off the device, but there is debate if this is sufficient. 

Design and manufacture of devices

Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by

substances or particles, including wear debris, degradation products and processing residues, that may be

released from the device.

Devices, or those parts thereof or those materials used therein that:

- are invasive and come into direct contact with the human body,

- (re)administer medicines, body liquids or other substances, including gases, to/from the body, or

- transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the

body, shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w)

where justified pursuant to Section 10.4.2:

(a) substances which are carcinogenic, mutagenic or toxic to reproduction ('CMR'), of category 1A or 1B, in

accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of

the Council (1), or

(b) substances having endocrine-disrupting properties for which there is scientific evidence of probable serious

effects to human health and which are identified either in accordance with the procedure set out in

Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once

a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of

Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the

criteria that are relevant to human health amongst the criteria established therein.