Classification and Route of Approval
Classification and Route of Approval for - Surgical Masks, N 95 Respirators, Surgical Gowns & Isolation Gowns
In the context of COVID-19, to protect health care workers as well as public, many medical devices as well as PPEs (Personal Protective Equipment) are used. Such products include - Masks, Respirators, and Gowns.
Surgical gowns and masks generally serve two purposes:
1. Protecting the patients
2. Protecting the wearer i.e Healthcare Providers / Public.
To meet the requirements of the global supply chain, approval of the device from the regulatory authorities is the 1st step. We will discuss about the regulatory route for approval of these products especially in the EU and US.
Surgical Masks:
EU:
Class: Medical Devices Directive – Class I
Route: Annex VII + Draw up the EC declaration of conformity
Requirement: ISO 13485 and Compliance with the essential requirements (Annex I) of Medical Device Directive
Testing (As per EN 14683):
- Bacterial filtration efficiency (BFE), (%) – Type I, II & IIR
- Differential pressure (Pa/cm2) – Type I, II & IIR
- Bacterial Filtration Efficiency Performance (%)
- Splash resistance pressure (kPa) – Only Type IIR
- Microbial cleanliness (cfu/g) – Type I, II & IIR
US:
Class: 2
Route: Pre-market notification 510(k)
Requirement: Compliance with 21 CFR Part 820
Testing (As per FDA Guidance):
- Fluid Resistance Performance (mmHg)
- Particulate Filtration Efficiency Performance (%)
- Bacterial Filtration Efficiency Performance (%)
- Differential Pressure (Delta-P) (mm H2O/cm2)
- Flammability class - Class 1
N 95 Respirators / FFP2 Valved or Unvalved:
EU:
Class: PPE Directive – Category III
Route: Annex V + Annex VII or Annex VIII
Requirement: Compliance with Quality System requirement and the essential (Annex II) of PPE Directive requirements
Testing (As per EN 149):
- Practical Performance
- Finish of Parts
- Leakage (total inward leakage & Penetration of filter material)
- Flammability
- Compatibility with skin
- CO2 content of the inhalation air
- Head harness
- Field of vision
- Exhalation Valve(s)
- Breathing resistance
- Clogging
- Demountable Parts (If applicable)
- Cleaning and Disinfecting (if reusable)
US:
Class: 2
Route: Pre-market notification 510(k)
Requirement: Compliance with 21 CFR Part 820
Testing (As per FDA Guidance):
- Fluid Resistance Performance (mmHg)
- Particulate Filtration Efficiency Performance (%)
- Bacterial Filtration Efficiency Performance (%)
- Differential Pressure (Delta-P) (mm H2O/cm2)
- Flammability class - Class 1
Surgical Gowns (Level I, II, III & IV):
EU:
Class: Medical Devices Directive – Class I
Route: Annex VII + Draw up the EC declaration of conformity
Requirement: ISO 13485 and Compliance with the essential requirements (Annex I) of Medical Device Directive
Testing (As per EN 13795):
- Microbial penetration – Dry
- Microbial penetration – Wet
- Cleanliness microbial / Bioburden
- Particle release
- Liquid penetration
- Bursting strength – Dry
- Bursting strength – Wet
- Tensile strength – Dry
- Tensile strength – Wet
US:
Class: 2
Route: Pre-market notification 510(k)
Requirement: Compliance with 21 CFR Part 820
Testing (As per ANSI/AAMI PB70):
- Level 1 – Water resistance in accordance with AATCC 42 (impact penetration)
- Level 2 & 3 – Water resistance in accordance with AATCC 42 (impact penetration) and Hydrostatic resistance
- Level 4 – Water resistance in accordance with AATCC 42 (impact penetration), Hydrostatic resistance and Resistance to bacteriophage (Virus)
Surgical Isolation Gowns (Level I, II, III & IV) / Coveralls:
EU:
Class: PPE Directive – Category III
Route: Annex V + Annex VII or Annex VIII
Requirement:Compliance with Quality System requirement and the essential (Annex II) of PPE Directive requirements
Testing (As per EN 14605 – Type 3 & 4):
- Resistance to penetration by Liquids – Whole Suits & Seams, joins and assemblages
- Resistance to permeation of liquids – Seams, joins and assemblages
- Seam strength – Seams, joins and assemblages
- Visor (For coveralls)
US:
Class: 2
Route: Pre-market notification 510(k)
Requirement: Compliance with 21 CFR Part 820
Testing (As per ANSI/AAMI PB70):
- Level 1 – Water resistance in accordance with AATCC 42 (impact penetration)
- Level 2 & 3 – Water resistance in accordance with AATCC 42 (impact penetration) and Hydrostatic resistance
- Level 4 – Water resistance in accordance with AATCC 42 (impact penetration), Hydrostatic resistance and Resistance to bacteriophage (Virus)
The classification of devices and its applicable directive may vary in the EU from the above- discussed criteria based on its intended use claimed by manufacturer as follows:
- If intended to protect the wearer: Personal Protective Equipment (PPE)
- If intended to protect the patient: Medical Device.
- If dual purpose: Medical Device and PPE
During the Covid-19 crisis, both EU and the US FDA has allowed for Emergency Use Authorizations (EUA) where a more liberal way of entering the market is allowed.