Nanomaterials? Products based on human cell or tissue derivatives?

#1
Could somebody please give me some examples of products that, according to the MDR new definitions, include:

-nanomaterials, or
-are based on human cell or tissue derivatives.

Thanks!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I'll start out by saying "I have no idea" but it seems like an interesting discussion so I'll jump in.

Regarding nanomaterials, the definition in the MDR seems a good starting point:

‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;

Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;


As far as products based on human cells, I don't know if this qualifies but I've seen reports of '3-D printers' depositing skin cells (for wound care I think).
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
I don't know much about the MDR, but I've been working with nanomaterials for a couple of decades...
They used to be call "sub-micron"...but "Nanoparticle" was sexier and got much more government funding.

I'm in ceramic processing, and ceramic strength increases (typically) with smaller grains.
Alumina (Al2O3) goes translucent...almost transparent...when the grains are small enough (or large enough)...read "great armored windows".
And thermal shock resistance improves (read torch nozzles and blast furnace ladles and crucibles).

Finer and finer ceramic particles also mean lower firing temperature...read "I can make an Al2O3 and gold integrated circuit, instead of having to use platinum which costs more.

Catalysis (read catalytic converter, gas sensing, vapor sensing, explosives residue detection at the airport, etc.) works by exposed surface...finer particle = more surface...

There are hundreds of ceramic nanoparticles (Al2O3, ZrO2, fume silica for dessicants, TiO2 for paint opacifiers, paper coatings to render higher quality images (less ink bleed), holograms printed onto beer bottles and windows, transparent solar cells (nano-silver particles to harvest power, but so fine you can't see them), etc.

Again, I don't know much about MDR...but these are the tip of the iceberg when it comes to nanoparticles currently market available.

Sumitomo Specialty Chemicals alpha alumina is available with particle sizes down to 30nm. Makes a nice smooth fired surface for magnetic recording media...or as a catalyst support for hydrogen separation...

HTH...I do not work for Sumitomo...
 
#4
Very interesting, I have also read that custom-made prosthesis are being made with 3D-printing. There is a technique called SLS, not sure if the size of the particles will fall into the nanomaterials category.
 
#5
Very interesting input, in which kind of medical devices will then these materials be used? Still trying to picture concrete examples of devices that may be affected by the MDR nanomaterial definition.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#6
Search terms to guide your search:

Forget "3D Printing"...that already had it's round in government funding...look for "Additive manufacturing" now...same thing, but free money guides vocabulary when new technologies are involved...

SLS (Selective Laser Sintering) is not printing...but is {sort of} an additive manufacturing process.
DOD (Drop on demand), UV matrix curing, LOM (Layered object manufacturing) and many many others are all swept together into "Additive Manufacturing".

Additive Manufacturing does not require nanomaterials...but nanomaterials can be used in an additive manufacturing process.

Nano particle suspension for diabetic blood testing...is this the example you are looking for? Or an ammonia sensor to breathe on to check glucose vs insulin ratio? Both of these use may nanoparticles in the sensing operation...

more surface = more catalysis = higher response signal = can use less material = cheaper/lighter/faster/disposable...
 
Thread starter Similar threads Forum Replies Date
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
T Information regarding Nanomaterials in Medical Devices EU Medical Device Regulations 6
Q Understanding "free movement" for CE-marked products EU Medical Device Regulations 2
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
Judy Abbott The impact of laser power on biocompatibility of the products Manufacturing and Related Processes 6
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
M Combination products - examples CE Marking (Conformité Européene) / CB Scheme 1
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
A Aesthetic products / indication EU Medical Device Regulations 6
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Multiple function device products EU Medical Device Regulations 0
Inggo28 Products Potentially Infected by Covid - 19 Human Factors and Ergonomics in Engineering 1
C Combination Products - Distributor of the device? EU Medical Device Regulations 7
A Can a US manufacturer put export only products on a CFG? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 3
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Old products new class - Dental Devices - Choosing tests EU Medical Device Regulations 2
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
R Reduced sampling plan for sterial products APQP and PPAP 0
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
J Raw material certificates - CC - Safety products - Sheet metal stamping IATF 16949 - Automotive Quality Systems Standard 1
M Validation of two nearly identical products Other Medical Device Regulations World-Wide 5
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
G Class IIa medical products - PMS report and PSUR EU Medical Device Regulations 6
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
F Calibrating Gagemaker Products General Measurement Device and Calibration Topics 1
C AS9100D -8.5.1j - Accountability For All Products Tiny Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M NANDO codes of products - These are not the GMDN codes, correct? EU Medical Device Regulations 4

Similar threads

Top Bottom