PPE Item Intended Purpose

Regulation EU & UK

Regulation (EU) 2016/425 on

Non Medical
personal protective equipment (PPE)

Masks &
Respirators (N95.)

Directive 93/42/EEC on medical

Medial
devices (MDD)

Regulation (EU) 2016/425 on

Non Medical
personal protective equipment (PPE)
Masks &
Respirators (Three
layer )
Directive 93/42/EEC on medical
devices (MDD) repealed by
Medial
Regulation 2017/745 (MDR) effective
from 26 May 2021.

Regulation (EU) 2016/425 on

Non Medical
personal protective equipment (PPE)

Protective Clothing -
Coverall/Gowns
Directive 93/42/EEC on medical
devices (MDD) repealed by
Medial
Regulation 2017/745 (MDR) effective
from 26 May 2021.

Directive 93/42/EEC on medical

devices (MDD) repealed by
Head Cover Medial
Regulation 2017/745 (MDR) effective
from 26 May 2021.
 Directive 93/42/EEC on medical
devices (MDD) repealed by
Shoe covers Medial
Regulation 2017/745 (MDR) effective
from 26 May 2021.

Directive 93/42/EEC on medical

Face shield & devices (MDD) repealed by
Medial
Goggles Regulation 2017/745 (MDR) effective
from 26 May 2021.

Regulation (EU) 2016/425 on

Non Medical
personal protective equipment (PPE)

Gloves
Directive 93/42/EEC on medical
devices (MDD) repealed by
Medical
Regulation 2017/745 (MDR) effective
from 26 May 2021.

Emergency
Exemptions https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32

Conformity
assessment https://ec.europa.eu/docsroom/docu
procedures for ments/40521/attachments/1/translati
protective equipment ons/en/renditions/native

https://european-
Accredited accreditation.org/coronavirus-outbreak-
laboratories for face accredited-laboratories-for-face-masks-
masks testing testing/

https://ec.europa.eu/growth/sectors/
mechanical-engineering/personal-
EU PPE protective-equipment/
 EU / UK

Conformity
Device Classificaitons
Assessment Route

Module C2
Annex VII
Category III under PPE
directive
Module D
(Annex VIII)

Class 1 (Non Sterile) Annex VII

Class I (Sterile)
Annex IV, V, VI

Module C2
Category III under PPE Annex VII
directive
Module D
(Annex VIII)

Class 1 (Non Sterile) Annex VII

Class I (Sterile)
Annex IV, V, VI

Module C2
Category III under PPE Annex VII
directive
Module D
(Annex VIII)

Class 1 (Non Sterile) Annex VII

Class I (Sterile)
Annex IV, V, VI

Class 1 (Non Sterile) Annex VII

Class I (Sterile)
Annex IV, V, VI
Class 1 (Non Sterile) Annex VII

Class I (Sterile)
Annex IV, V, VI

Class 1 (Non Sterile) Annex VII

Class I (Sterile)
Annex IV, V, VI

Module C2
Category III under PPE Annex VII
directive
Module D
(Annex VIII)

ANNEX II – A system
Class II a (Sterile)
with
full quality assurance
 EU / UK

Certification Bodies for

System Certification - QMS / GMP Requriements
QMS

Annex VIII -
Section 3 - Quality System
(ISO 9001 - Recommended)

- -
IV - EC Verification (Evaluation and testing of device)
V - Production Quality Assurance (covering production, final test etc)
VI - Product Quality Assurance (Covers final test and inspection only) EU Approved Notified
(ISO 13485 - Recommended) Body Lab

Annex VIII -
Section 3 - Quality System
(ISO 9001 - Recommended)

- -
IV - EC Verification (Evaluation and testing of device)
V - Production Quality Assurance (covering production, final test etc)
VI - Product Quality Assurance (Covers final test and inspection only) EU Approved Notified
(ISO 13485 - Recommended) Body Lab

Annex VIII -
Section 3 - Quality System
(ISO 9001 - Recommended)

- -
IV - EC Verification (Evaluation and testing of device)
V - Production Quality Assurance (covering production, final test etc)
VI - Product Quality Assurance (Covers final test and inspection only) EU Approved Notified
(ISO 13485 - Recommended) Body Lab

- -
IV - EC Verification (Evaluation and testing of device)
V - Production Quality Assurance (covering production, final test etc)
VI - Product Quality Assurance (Covers final test and inspection only) EU Approved Notified
(ISO 13485 - Recommended) Body Lab
 - -
IV - EC Verification (Evaluation and testing of device)
V - Production Quality Assurance (covering production, final test etc)
VI - Product Quality Assurance (Covers final test and inspection only) EU Approved Notified
(ISO 13485 - Recommended) Body Lab

- -
IV - EC Verification (Evaluation and testing of device)
V - Production Quality Assurance (covering production, final test etc)
VI - Product Quality Assurance (Covers final test and inspection only) EU Approved Notified
(ISO 13485 - Recommended) Body Lab

Annex VIII -
Section 3 - Quality System
(ISO 9001 - Recommended)

IV - EC Verification (Evaluation and testing of device)

V - Production Quality Assurance (covering production, EU Approved Notified
final test etc) Body Lab
(ISO 13485 - Recommended)
 Product Certification
Product Testing
Agency (Approvals / Remarks
Lab
Registrations)

EU Approved
Notified Body Lab
NANDO - Notified Bodies for PPE
ISO/IEC 17025
Accredited Labs

ISO/IEC 17025 Lab

List Self Decleration

EU Approved NANDO Notified Bodies for MDD

Notified Body Lab

EU Approved
Notified Body Lab
NANDO - Notified Bodies for PPE
ISO/IEC 17025
Accredited Labs

ISO/IEC 17025 Lab

List Self Decleration

EU Approved NANDO Notified Bodies for MDD

Notified Body Lab

EU Approved
Notified Body Lab
NANDO - Notified Bodies for PPE
ISO/IEC 17025
Accredited Labs

ISO/IEC 17025 Lab Example for EU

List Self Decleration type examination
SGS India /SGS
EU Approved NANDO Notified Bodies for MDD
UK /SGS Finland
Notified Body Lab

ISO/IEC 17025 Lab

List Self Decleration

EU Approved NANDO Notified Bodies for MDD

Notified Body Lab
ISO/IEC 17025 Lab
List Self Decleration

EU Approved NANDO Notified Bodies for MDD

Notified Body Lab

ISO/IEC 17025 Lab

List Self Decleration

EU Approved NANDO Notified Bodies for MDD

Notified Body Lab

EU Approved
Notified Body Lab
NANDO - Notified Bodies for PPE
ISO/IEC 17025
Accredited Labs

EU Approved
NANDO Notified Bodies for MDD
Notified Body Lab
 Regulation Device Classificaitons

The Food and Drug Administration (FDA)

21 CFR 878.4040
Class II
21 CFR 880.6260*

Respiratory Protective Devices - 42 CFR

-
84

The Food and Drug Administration (FDA)

21 CFR 878.4040
Class II
21 CFR 880.6260*

Nonsurgical gowns - Class 1

21 CFR 878.4040 Surgical apparel

Surgical gowns - Class II

The Food and Drug Administration (FDA)

Class II
21 CFR 878.4040
The Food and Drug Administration (FDA)
Class II
21 CFR 878.4040

The Food and Drug Administration (FDA)

Class II
21 CFR 878.4040

Patient Examination gloves (21 C.F.R.

§880.6250)
Class I
Surgical Gloves (21 C.F.R. §878.4460).

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe
 US

System Certification - QMS / GMP

Conformity Assessment Route
Requriements

Subject to Premarket Notification FDA 21 CFR Part 820

Submission [510(k)] (ISO 13485 recommended)

Threshold Evaluation Review by

-
NIOSH

Subject to Premarket Notification FDA 21 CFR Part 820

Submission [510(k)] (ISO 13485 recommended)

Exemption from exempt from premarket

review (i.e., 510(k) notification or PMA
approval FDA 21 CFR Part 820
(ISO 13485 recommended)
Subject to Premarket Notification
Submission [510(k)]

Subject to Premarket Notification FDA 21 CFR Part 820

Submission [510(k)] (ISO 13485 recommended)
Subject to Premarket Notification FDA 21 CFR Part 820
Submission [510(k)] (ISO 13485 recommended)

Subject to Premarket Notification FDA 21 CFR Part 820

Submission [510(k)] (ISO 13485 recommended)

Subject to Premarket Notification FDA 21 CFR Part 820

Submission [510(k)] (ISO 13485 recommended)
 Product
Certification Bodies for QMS Certification Agency
Product Testing Lab
and GMP (Approvals /
Registrations)

ISO 13485 CB List (NABCB or

ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)

ISO/IEC 17025 Lab List

- NIOSH
/ NIOSH Approved Lab

ISO 13485 CB List (NABCB or

ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)

ISO 13485 CB List (NABCB or

ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)

ISO 13485 CB List (NABCB or

ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)
ISO 13485 CB List (NABCB or
ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)

ISO 13485 CB List (NABCB or

ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)

ISO 13485 CB List (NABCB or

ISO/IEC 17025 Lab List US FDA
IAF Member accredited list)
Remarks