Herbal ingredients MDR

Ben S UK

Starting to get Involved
#1
Hi,

Had a quick question on the use of herbal ingredients within a substance based device, under the MDR. No specific herbal ingredient has been identified so this is a bit theoretical.

The MDR doesn't have any specific (explicit) restrictions on the use of herbal ingredients in devices.

Aside from ensuring there is no PIM mode of action, i.e. the herbal ingredient either has a physical mode of action, or is in the product for a secondary benefit (not PIM) such as flavour, are there any watch outs?

I'm mindful there have been rulings on herbals in the borderline guidance which has focused on MoA - Icelandic Moss. But assuming the herb is not PIM, even if it is listed as a Herbal medicine (based on longstanding use) or the herbal monograph, I don't see a fundamental issue with using them.

Wondered if anyone had any thoughts?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
D Requirements for Ingredients or Actives in the USA US Food and Drug Administration (FDA) 3
D Requirements for Storage of Food Allergen Ingredients Manufacturing and Related Processes 1
AnaMariaVR2 Drugmakers fight against sport-enhancing ingredients US Food and Drug Administration (FDA) 0
P How to get FDA Approval of an API (Active Pharmaceutical Ingredients) Plant in India US Food and Drug Administration (FDA) 3
M ISO 22000 - HACCP plan for ingredients like Egg Powder, Strawberry Flavour and Butter Food Safety - ISO 22000, HACCP (21 CFR 120) 2
T Validation of water system in API (Active Pharmaceutical Ingredients) unit Qualification and Validation (including 21 CFR Part 11) 5
R Process Validation Issues - Active Pharmaceutical Ingredients Qualification and Validation (including 21 CFR Part 11) 2
A Cosmetics - List of Banned ingredients in the US ISO 13485:2016 - Medical Device Quality Management Systems 5
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 1
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 3
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
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
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
M MDR harmonized standards EU Medical Device Regulations 3
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
E MDR PRRC "jointly responsible" EU Medical Device Regulations 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
U EU-MDR: Complicated supply chain EU Medical Device Regulations 4
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Internal Auditing 1
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1

Similar threads

Top Bottom