Authorized Body No. 201
Notified Body No. 1014
Accredited Testing and Calibrating Laboratory
Accredited Body for the Certification of Products and
Systems of Management
Ordering number
Do not fill, will be filled by EZÚ
of medical devices
according to MDD 93/42/EEC
of active implantable medical devices
according to AIMD 90/385/EEC
- Full quality assurance system – Annex II
EC type examination – Annex III
- EC verification
– Annex IV
- Production quality assurance
– Annex V
- Product quality assurance
– Annex VI
1 ORDERING PARTY
The ordering party is:
- Full quality assurance system
– Annex 2
EC type examination
– Annex 3
-
-
EC verification
Production quality assurance
Manufacturer
OBL
Authoritative representative
– Annex 4
– Annex 5
VAT payer
Natural person
Legal entity
Trade name:
Address:
VAT number:
Contact person:
Bank account:
Phone: Contact person:
Authorized for contract negotiation:
Statutory representative:
Position:
Position:
2 OTHER WORKPLACES UNDER CERTIFICATION PROCESS (design, production, branch office, etc.)
(It does not relate to external subcontractors and outsourced processes.)
Trade name Address Processes and activities
EZÚ, s.p.
Pod Lisem 129
171 02, Prague 8 – Troja tel.: + 420 266 104 111 fax: + 420 284 680 070
Komer č ní banka, Prague
8
SWIFT: KOMBCZPP ID No.: 00001481
Czech Republic www.ezu.cz Account: 180681/0100 VAT No.:
Registered in the Trade Register administered by the City Court of Prague, section A, Inlet No. 33767
CZ00001481
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3 MANUFACTURER OUTSIDE EU DEPUTIZE BY AUTHORITATIVE REPRESENTANTIVE
Trade name:
Address:
Contact person:
4 MEDICAL DEVICE UNDER CERTIFICATION PROCESS
Class:
I sterile I with measuring function
I sterile with measuring function
IIa IIb III
Category:
Non-active devices for anaesthesia, emergency and intensive care
Non-active devices for injection, infusion, transfusion and dialysis
Non-active orthopaedic and rehabilitation devices
Non-active medical devices with measuring function
Non-active ophthalmologic devices
Non-active instruments
Contraceptive medical devices
Non-active medical devices for disinfecting, cleaning, rinsing
Devices for extra-corporal circulation, infusion and haemopheresis
Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Devices for stimulation or inhibition
Active surgical devices
Active ophthalmologic devices
Active dental devices
Active devices for disinfection and sterilisation
Active rehabilitation devices and active prostheses
Non-active implants
Bandages and wound dressings
Suture material and clamps
Other medical devices for wound care
Non-active dental equipment and instruments
Dental materials
Dental implants
Active devices for patient positioning and transport
Software
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
Active implantable medical devices
Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
Medical devices utilising tissues of animal origin, including Regulation 722/2012
Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed
Other:
Medical device or category of medical devices:
(In the case of category of medical devices is necessary to append to the application complete list of products covered by this category including types, models, versions, etc.)
Trade name:
Model (typ)/version:
(
For more models (types)/versions please add to the application complete list of these models (types)/versions with description of differences of each model (type)/version.)
Used classification rule according to Annex IX:
Intended use:
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Short description (material composition):
(Short description means basic technical information and description of basic function for active medical devices, for other medical devices short description means composition of the device, mainly used materials and substances.)
Active substance:
List of standards applicable to the medical device:
Type of sterilization (for medical devices put sterile on the market) :
Radiation sterilization (ISO 11137-1) Ethylene oxide sterilization (ISO 11135-1)
Steam sterilization (ISO 17665-1) other
Identification of Technical file or Design Dossier
5 ADDITIONAL SPECIFICATIONS OF MEDICAL DEVICE
The medical device contents medicine as its integral part
Identification of used medicine:
Number of EDQM certificate (if exists) :
The medical device contents tissues of animal origin:
Identification of used animal tissue:
Origin of animal tissue:
Number of EDQM certificate (if exists) :
The medical device contents human blood derivate
YES / NO
YES / NO
YES / NO
The medical device contents phthalates
6 OTHER CERTIFICATION MARKS
The manufacturer has certified system according to ISO 9001
YES / NO
The manufacturer has certified system according to ISO 13485
YES / NO
YES / NO
The manufacturer has valid CE certificate from another Notified Body YES / NO
The manufacturer transfers from another Notified Body YES / NO
The reason for changing the Notified Body:
The name of previous Notified Body:
The number of previous certificate:
The validity of previous certificate:
7 QUESTIONNAIRE BEARS ON QUALITY ASSURANCE (refer to Annex II(2), V(5) and VI(6))
Number of employees participate on production (including branch offices) and under
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certification process:
The manufacturer ensures:
Design and development
EXTERNALLY Name and address of external supplier:
Note:
Production
EXTERNALLY Name and address of external supplier:
Note:
Final assembly
EXTERNALLY Name and address of external supplier:
Note:
Final inspection
EXTERNALLY Name and address of external supplier:
Note:
Product testing
EXTERNALLY Name and address of external supplier:
Note:
Packaging
EXTERNALLY Name and address of external supplier:
Note:
Sterilization
EXTERNALLY Name and address of external supplier:
Note:
Clean room
EXTERNALLY Name and address of external supplier:
Note:
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
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Warehousing
EXTERNALLY Name and address of external supplier:
YES
NO
Note:
The manufacturer purchases:
Critical components
Identification of purchased components:
Semi-finished products
Identification of purchased semifinished products:
Critical services
Identification of purchased services:
The manufacturer makes procedure packs from medical devices:
from own medical devices
from medical devices without CE
from medical devices with CE
Note:
YES
NO
YES
NO
YES
NO
8 MANUFACTURERS DECLARATION
The manufacturer declares:
1.
no application has been lodged with any other notified body for the same product-related quality system
2.
an undertaking to fulfil the obligations imposed by the quality system approved
3.
an undertaking to keep the approved quality system adequate and efficacious
4.
to submit complete documentation necessary for certification process to notified body
5.
an undertaking to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action, this undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them
9 CONDITIONS OF SUBMITTING THE APPLICATION
1.
Properly fulfilled signed application is binding.
The scope of certification audit is prepared on the basis of submit application, appropriate changes against written application is possible to announce one week before certification audit at the latest. Changes announce during the certification audit cannot be accepted.
2.
The application must be filled in electronic format, printed and signed.
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3.
For certification according to both directives please fill two separate applications.
4.
For certification according to two or more annexes please fill for each separate application.
5.
One application is to be submitted in for each subgroup, or a generic group of MD separately. A separate application must be submitted for MD with Design Dossier either.
6.
For each OEM please filled separate application.
7.
In the case of OBL certification the copy of OEM certificate and signed contract between OEM and OBL with valid conversion table is the inseparable part of the application.
8.
It is necessary to submit the documentation of the quality system according to relevant requirements of the Directive together with the application. The documentation must include at least: a general description of the product, including any variants planned and its intended use, design drawings with description of production technology, the descriptions necessary to understand the functioning of the product, the risk analysis, the description of used sterilization methods (it relates only to sterile products or products intended for sterilization), essential requirements according to Annex I, pre-clinical and clinical evaluation, draft of labels and instruction for use
9.
It is possible to accept and register only complete and correctly filled application.
10.
If it is not possible to accept the application, the Notified Body representative will inform the ordering party in written way within 14 days. The application can be also refused if some of requested documents are repeatedly missing.
Date and place
Do not fill, will be filled by EZÚ
Stamp:
Sign of ordering party
Electrotechnical testing institute as Notified Body No. 1014 the above mentioned application
ACCEPT DOES NOT ACCEPT
The reason for non-acceptance of the application:
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Date Sign of Notified body representative
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