Sr.

No PPE Item Intended Purpose

Non Medical
Masks & Respirators
(N95.)

Medial
1

Masks & Respirators Non Medical

(Three layer )

Masks & Respirators

Medial
(Three layer )

Non Medical
Protective Clothing -
2 Coverall/Gowns
Medial

Non Medical

3 Head covers

Medial

4 Shoe covers Non Medical

5 Face shield & Goggles Non Medical

Non Medical

6 Gloves
 6 Gloves

Medical

Note

Exceptions to the
conformity assessment
1 rules for PPE
Personal protective
2 equipment (PPE)
 EU

Regulation EU & UK Device Classificaitons

Regulation (EU) 2016/425 on personal protective Category III under PPE directive
equipment (PPE)

Directive 93/42/EEC on medical devices (MDD) repealed

by Regulation 2017/745 (MDR) effective from 26 May Class 1 (Sterile)
2021.

Regulation (EU) 2016/425 on personal protective Category III under PPE directive
equipment (PPE)

Directive 93/42/EEC on medical devices (MDD) repealed Class 1 (Sterile)

by Regulation 2017/745 (MDR) effective from 26 May
2021.

Regulation (EU) 2016/425 on personal protective

equipment (PPE) Category III under PPE directive

Directive 93/42/EEC on medical devices (MDD) repealed Class 1 (Non Sterile / Sterile)
by Regulation 2017/745 (MDR) effective from 26 May
2021.

Regulation (EU) 2016/425 on personal protective

Category III under PPE directive
equipment (PPE)

Directive 93/42/EEC on medical devices (MDD) repealed Class 1 (Non Sterile / Sterile)
by Regulation 2017/745 (MDR) effective from 26 May
2021.

Regulation (EU) 2016/425 on personal protective

equipment (PPE) Category III under PPE directive

Regulation (EU) 2016/425 on personal protective

equipment (PPE) Category III under PPE directive

Regulation (EU) 2016/425 on personal protective

Category III under PPE directive
equipment (PPE)
Directive 93/42/EEC on medical devices (MDD) repealed
Class 1 (Non Sterile / Sterile)
by Regulation 2017/745 (MDR) effective from 26 May
2021.

https://www.eu-esf.org/covid-19/4519-covid-19-exceptions-to-the-conformity-assessment-rules-for-ppe

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

System Certification Certification Bodies

Conformity Assessment Route - QMS / GMP Product Testing Lab
Requriements for QMS

EU type-examination (Module ISO 9001 NABCB CB ISO/IEC 17025 Lab

B) ISO 9001
Module D Lists List

Annex VI ISO 13485 ISO 13485 NABCB CB ISO/IEC 17025 Lab

Lists List

EU type-examination (Module
B) ISO 9001 ISO 9001 NABCB CB ISO/IEC 17025 Lab
Module D Lists List

ISO 13485 NABCB CB ISO/IEC 17025 Lab

Annex VI ISO 13485
Lists List

EU type-examination (Module
ISO 9001 NABCB CB ISO/IEC 17025 Lab
B) ISO 9001 Lists List
Module D

Non Sterile - Annex VII ISO 13485 NABCB CB ISO/IEC 17025 Lab
Sterile - Annex VI ISO 13485 Lists List

EU type-examination (Module ISO 9001 NABCB CB ISO/IEC 17025 Lab

B) ISO 9001
Module D Lists List

Non Sterile - Annex VII ISO 13485 NABCB CB ISO/IEC 17025 Lab
ISO 13485
Sterile - Annex VI Lists List

EU type-examination (Module
ISO 9001 NABCB CB ISO/IEC 17025 Lab
B) ISO 9001 Lists List
Module D

EU type-examination (Module ISO 9001 NABCB CB ISO/IEC 17025 Lab

B) ISO 9001 Lists List
Module D

EU type-examination (Module ISO 9001 NABCB CB ISO/IEC 17025 Lab

B) ISO 9001
Module D Lists List
Non Sterile - Annex VII ISO 13485 NABCB CB ISO/IEC 17025 Lab
Sterile - Annex VI ISO 13485 Lists List
Product Certification
Agency (Approvals / Remarks Regulation
Registrations)

NANDO PPE database

The Food and Drug Administration (FDA) 21
CFR 878.4040

21 CFR 880.6260*
NANDO MDR database

NANDO PPE database

The Food and Drug Administration (FDA) 21
CFR 878.4040

NANDO MDR database 21 CFR 880.6260*

NANDO PPE database

21 CFR 878.4040 Surgical apparel

Non Sterile - Self
Decleration. Sterile -
NANDCP PPE Example for EU type
Database examination SGS
India /SGS UK /SGS
Finland
NANDO PPE database

Note -1
Non Sterile - Self
Decleration. Sterile -
NANDCP PPE
Database

NANDO PPE database Note -1

NANDO PPE database Note -1

NANDO PPE database

Note -1
 Note -1
Non Sterile - Self
Decleration. Sterile -
NANDCP PPE
Database

Note 1 - https://www.fda.gov/medical-
devices/personal-protective-equipment-
infection-control/medical-gloves-covid-19-
manufacturing-purchasing-importing-and-
donating-gloves-during-public-health
 US

Device Classificaitons Conformity Assessment Route

Subject to Premarket Notification

Class II
Submission [510(k)]

Class II Subject to Premarket Notification

Submission [510(k)]

Class II (special controls) for surgical Subject to Premarket Notification

gowns Submission [510(k)]
 US

Certification Bodies for QMS and

System Certification - QMS / GMP Requriements
GMP

ISO 13485 CB List (NABCB or IAF

ISO 13485 + GMP
Member accredited list)

ISO 13485 + GMP ISO 13485 CB List (NABCB or IAF

Member accredited list)

ISO 13485 CB List (NABCB or IAF

ISO 13485 + GMP Member accredited list)
 Product Certification
Product Testing Lab Agency (Approvals / Remarks
Registrations)

ISO/IEC 17025 Lab List US FDA

ISO/IEC 17025 Lab List US FDA

ISO/IEC 17025 Lab List US FDA