Medical Devices New Application Review Form

Medical Devices – New Application Review Form

Applicant Information

Please tick all that apply:

NEW APPLICATION

Own Brand Label (OBL) Transfer (from another NB)

Fast Track (expedited) Modular (partial application)

P/O number:

Directive(s) that apply :NSAI File Number

MDD (93/42/EEC)252./

AIMD (90/385/EEC)253./

TSE Human Blood Medicinal Substances

If OBLs apply to this product, please state the relevant product families below:

/; /; /

INSTRUCTIONS

Please complete all relevant sections of the form (excluding the NSAI Review sections).

Please enter as much information onto the form as possible - avoid entering “see Technical File/Design Dossier”. If the data is in supporting documentation, please ensure that there is a clear reference to the exact location of this information.

Please submit an unsigned version of this Application in Word as well as a signed copy - either scanned/secured (pdf) copy.

All application forms and supporting data to be forwarded in soft copy via one of the following (Hard copies not required)
NSAI upload facility : see
CD or Memory stick to the appropriate address

Europe / N. America
NSAI
1 Swift Square,
Northwood,
Santry, Dublin 9
Ireland
Phone : (01) 807 3929
Fax : (01) 807 3996
/ NSAI Inc.
402 Amherst Street
Nashua
NH 03063
USA
Phone : (603) 882 4412
Fax : (603) 882 1985

Supporting documents should be in SEARCHABLE format

Applications and supporting documentation must be in English

Please send a representative sample of the device(s). This is particularly important for new/novel devices. Any video of procedures/simulated use would also be helpful, if available.

APPLICANTS’ SUBMISSION CHECKLIST

Completed application form (Word format, .doc or .docx)

Application (min. Signed Declaration page(s)) scanned

Sample of device(s)

QMS certificates for any sites in Table 1 NOT registered with NSAI

Type Examination Certificate if required

(Draft) Declaration of Conformity

(Draft) Labelling & IFU

Essential Requirements Checklist

Performance/Complaint Analysis

Risk Management documentation

Sterilisation Validation(s) – if sterile/intended to be sterilised

Stability data – if necessary

Biocompatibility data – if necessary

Electrical Safety Testing data – if necessary

Software/firmware lifecycle documents – if necessary

Bench Testing data – if necessary

Clinical investigation(s) report(s) and supporting documents per MEDDEV 2.7.1.

NSAI Equivalence table RF-25-28 if using equivalent route

NSAI Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF)RF-25-27

Note – NSAI do not accept “For Information Only Data” (FIO); all attributes tested shall have clinically relevant specifications

For Transfers

Copy of existing Notified Body Certificate(s)

(If not already supplied)

Transition Plan

Contact details for existing Notified Body

(NSAI will not contact the existing Notified Body prior to agreement with the Manufacturer)

For Own Brand Labeller (OBL)

Copy of the OEM (maker’s) CE Certificate and last assessment reports from their Notified Body

Copy of the OEM’s Declaration of Conformity

Traceability between OEM cert & devices covered in this application

Copy of the contract between OBL & OEM outlining responsibilities

Index for Technical documentation/Design dossier (version/date), listing supporting documents

Copy of the OEM’s Instructions for Use/Labelling

For Tissue of Animal Origin falling under TSE Regulation 722/2012 EU

Please complete Appendix A

For Human Blood Derivatives

Please complete Appendix B

For Medicinal Substances.

Please complete Appendix C

DECLARATION(s) BY APPLICANT

In making this application we declare:

The information in this form is correct
We have not lodged an application with any other notified body to undertake conformance assessment procedures for the same product(s) / device-related quality system mentioned.
We undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions and notifications, taking account of the nature and risks in relation to this product.
We agree to inform/notify the Competent Authorities and NSAI of the following incidents immediately on learning of them:

iany malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to, or might have led to the death of a patient or user or other persons or a serious deterioration in his or their state of health.

iiany technical or medical reason connected with the characteristics or the performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.

We agree to pay all applicable fees and understand that non-payment of fees will result in withdrawal of approval.
We undertake to fulfil the obligations imposed by the quality system approved
We undertake to keep the approved quality system adequate and efficacious.
We agree to inform NSAI that approved the quality system of any plan for substantial changes to the quality system or the product-range covered.
We shall inform NSAI which issued the EC design-examination certificate of any changes to the approved design, wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for the use of the device.
We authorise NSAI to carry out all the necessary inspections and supply it with all relevant information, in particular:
- The documentation on the quality system
- The data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests etc., (where relevant)
- The data stipulated in the part of the quality system relating to manufacture such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
On receipt of the CE Mark approval from NSAI, it is our intention to commercialise the product. In the event of non-commercialise of the said product we commit to notify NSAI of this decision.

ADDITIONAL DECLARATIONS for devices containing Human Blood Derivatives – Directive 2000/70/EC only –

We undertake to inform NSAI of the release of each batch of devices upon completion of each batch, and to send the official certificate concerning release of the batch of human blood derivative used in the device, issued by as State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 4(3) of Directive 89/381/EEC.

By Signing below, I accept the above declarations

Signed on behalf of the Manufacturer: / Date:
Name (please print):
Position / Title:
Contact person (if different to Manufacturer):
e-mail: / Phone:

Table of Contents:

Applicant Information

INSTRUCTIONS

APPLICANTS’ SUBMISSION CHECKLIST

DECLARATION(s) BY APPLICANT

Section 1 – Manufacturer and Product Details

Section 2 – Description of Device

Section 3 – Intended Use of the Device

Section 4 – Previous Existing Legislation

Section 5 – Labelling and IFU

Section 6 – Solutions to Essential Requirements and Harmonised Standards

Section 7 – Performance / Complaint Analysis

Section 8 – Risk Management

Section 9 – Sterilisation

9.1 – Sterilisation Validation

9.2 – Maintenance of Sterility over shelf life

Section 10 – Biocompatibility

Section 11 – Medical Electrical (ME) Equipment & Systems, plus Software

Section 12 – Device Testing

12.1 – Device Design Testing

12.2 - Device Stability

Section 13 - Clinical Testing (Animal Model)

13.1 In Vivo Clinical Performance

13.2 In Vivo Device Performance

Section 14 – Clinical Performance (Human)

14.1 Clinical Evaluation

14.2 Drug/Device combinations only

Section 15 – Other Information

Section 16 – Critical Process Details

Section 17 – Additional Information

Section 18 - NSAI Queries

18.1 Queries, Responses and Dispositions.

18.2 Query Status Table:

Section 19 - Conclusion of Assessment

Approval

Section 20 – Medical Devices Supplemental Review Form

APPENDIX A

APPENDIX B

APPENDIX C

Section 1 – Manufacturer and Product Details

Note the “Manufacturer” as defined by the Directive(s) is “the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

Table 1 – Manufacturers Information & Summary Product data

(Legal) Manufacturer’s Name
(Legal) Manufacturer’s Address
Design Site(s):
Manufacturing Site(s):
(i.e. sites of actual manufacture)
Assembly Site(s) if applic.:
Sterilisation Site(s) if applic.:
Scope of Site(s):
(i.e. as shown on the QMS cert)
Name and address of EU Authorised Representative
(if applicable)
Product/Product Family Name:
(In compliance with NB/MED/2.5.1/REC4 & NBOG’S Best Practice Guide 2006-2)
GMDN Reference Number: / See
Declaration of Conformity included - Location within submission :
MDD ONLY :
Class / III IIb IIa Is Im / Rule(s)
Rationale
Conformity Assessment / Annex II / V (+VII) / V + III / VI
Full QA / Prodn QA / + Type Testing / Product QA
AIMD ONLY :
Conformity Assessment / Annex 2 / Annex 3 + 5
Full QA / Prodn QA + Type Testing
ALL DEVICES :
Clinical Strategy-
- Clinical data from: / Clinical Investigation
Literature (Equivalence)
Combination
Date of this application (i.e. date of Declaration of Applicant)

Please complete the Table below, providing a full and up-to-date list of the current model numbers and descriptions related to this Application.

If the Declaration of Conformity is being used (instead of completing Table 2), please make sure that the WORD version is supplied.

Table 2 – Product Family Information

Sub-Family / Model/Catalogue Number / Description / Class

NSAI REVIEW

NSAI registration(s) -

If Annex II is “Design” included in scope Yes No

Sites listed above registered to EN ISO 13485:2003 by another Notified Body if not with NSAI

Client QMS Certificates are valid and scope of registration(s) remains adequate for product family under review

Any subcontracted activities

Product family name in line with GMDN

DoC reviewed - lists model numbers

All classification rules reviewed (MDD Only)

Agree with Classification - Yes No

Appropriate Conformity Assessment route

Type Testing Certificate required – No Yes – if so Supplied, Valid

Clinical strategy provided

Models match with technical documentation

NSAI REVIEW

Technical Reviewer Date:

COMMENTS:

Clinical Reviewer (if requested) Date:

COMMENTS:

Additional Reviewer (if requested) Date:

COMMENTS:

QUERIES No YesNumber(s)

Section 2 – Description of Device

Please provide a full description of the device which demonstrates that the product is covered under the relevant Directive:

Device Description:

NSAI REVIEW

Description sufficiently detailed and accurate (See NBOG 2009-1 p.3)

Product is a MEDICAL DEVICE or ACTIVE IMPLANTABLE MEDICAL DEVICE

(as defined in Article 1 of MDD or AIMD)

NSAI REVIEW

Technical Reviewer Date:

COMMENTS:

Clinical Reviewer (if applicable) Date:

COMMENTS:

Additional Reviewer (if applicable) Date:

COMMENTS:

QUERIES No YesNumber(s)

Section 3 – Intended Use of the Device

Please enter a full description of the intended use of the device, which supports the product classification:

List of any contra-indications :

List of any precautions / warnings :

Ensure traceability between the Risk Management File, the CER and Labelling is evident

Yes No

Is the product family Class III or IIb Implantable Yes No

For class III and Class IIb implantables ONLY,

Please outline the “Indications for use” (i.e. specific patient population intended for this device/family).

NSAI REVIEW

Intended Use clearly stated

Intended Use in line with labelling

Intended Use described supports classification

Indications for Use clearly stated (Class IIb or Class III only)

NSAI REVIEW

Technical Reviewer Date:

COMMENTS:

Clinical Reviewer (if applicable) Date:

COMMENTS:

Additional Reviewer (if applicable) Date:

COMMENTS:

QUERIES No Yes Number(s)

Section 4 – Previous Existing Legislation

Does the device have any existing approvals (e.g. FDA 510(k)) Yes No

If “Yes” – please advise -

Does this product, labelled with your Name & Address carry CE Marking with another Notified Body Yes No

If “Yes” – this is considered a TRANSFER

Please supply

A copy of the existing certificate
Transition plan (e.g. planned communication with existing Notified Body, projected timelines for ending the use of the existing Notified Body Number)
Contact details for the existing Notified Body

NOTE – NSAI will not contact the existing Notified Body prior to agreement with the (Legal) Manufacturer.

If you are not the actual Maker of the device, does this identical product carry CE marking by the maker? Yes No

If “Yes” – this is considered OWN BRAND LABELLING

The conformity assessment by NSAI relating to the device itself will consist of verifying that the existing CE Marking conformity approval held by the OEM manufacturer (the “third party” providing the device to the “own brand labelling” manufacturer) is valid and current, and that the device in question is the same device.

In addition to the information requested in other sections, please supply

Index for technical documentation / design dossier (version/date), listing supporting documents such as reference to OEM manufacturer’s Technical File
Copies of the current CE Marking conformity approval and quality systems approval from the original CE Marking manufacturer of the device, including last assessment reports from their Notified Body, and a copy of their Declaration of Conformity
Contract agreement between “own brand labelling” manufacturer and the original CE Marking manufacturer. This should include :
Clear identification of the devices covered, product specifications
OEM manufacturer will maintain his CE Marking and quality system approvals, and notify of any certificate withdrawal or change
OEM manufacturer to provide notification of significant changes / vigilance reports / product recalls and corrective actions taken
access to technical documentation for OBL manufacturer or at least direct access for regulatory parties such as the Notified Body or Competent Authorities
OEM manufacturer to maintain the records and other documentation relating to the batches being “own brand labelled” for an agreed period of time
Copy of the OEM manufacturer’s device Instructions for Use/packaging, to allow confirmation that the same claims are being made for the device

NSAI REVIEW

Previous approvals

Transfer: Current cert. Transition plan Contacted existing NB

No outstanding issues

OBL: OEM cert Contract (OBL/OEM) Responsibilities OK

NSAI REVIEW

Technical Reviewer Date:

COMMENTS:

Additional Reviewer (if applicable) Date:

COMMENTS:

QUERIES No YesNumber(s)

Section 5 – Labelling and IFU

Location of the sample Label(s) & IFU in the supporting documentation

Please include all levels of labelling – device, packaging, carton, etc.

Note - Draft labelling is acceptable for New Applications

If the IFU being used electronic? YesNo

If “Yes”, please submit evidence of compliance with Council Regulation 207-2012 for electronic IFU.

Please advise how language requirements of the countries where the device is to be placed on the market have been fulfilled -

Are the requirements of labelling standards being met Yes No

Version of Standard – EN 1041: EN ISO 15986: EN 15223-1:

If “No” please justify -

Is the device Medical Electrical Equipment Yes No

If “Yes”

Are the requirements of EN 60601-1 being met Yes No N/A

Version of Standard:

If “No” please justify -

Are the requirements of EN 60601-1-6 being met Yes No N/A

Version of Standard:

If “No” please justify -

Do any vertical labelling standards apply Yes No

[Note : Vertical labelling standards are any specific product standards that include requirements for labelling – e.g. EN 455 – Gloves, EN ISO 7886-4 syringes with re-use prevention, EN 1282-2 Paediatric tracheostomy tubes].

If “Yes”, please list (including current version) -

If compliance with these vertical labelling standards is not claimed, please justify -

NSAI REVIEW

Labels reviewed – details

All relevant parts of ER 13, particularly 13.3 (MDD) or ER 14 (AIMD) met

IFU reviewed – details

All relevant parts of ER 13, particularly 13.6 (MDD) or ER 15 (AIMD) met

Ensure traceability between the Risk Management File and the CER and labelling

Symbols & Markings on ME Equipment/System are per Table D.1, D.2, D.3 of EN 60601-1

Markings & IFU in line with EN 60601-1-2 (EMC)

For OBL – OEM IFU claims in line with OBL IFU

Vertical labelling standards -

NOTE – If an issue is identified with the sample labelling, ensure that the corrective action(s) are applied to all labelling operations.

NSAI REVIEW

Technical Reviewer Date:

COMMENTS:

Clinical Reviewer (if applicable) Date:

COMMENTS:

Additional Reviewer (if applicable) Date:

COMMENTS:

QUERIES No YesNumber(s)

Section 6 – Solutions to Essential Requirements and Harmonised Standards

Location of the solutions to Essential Requirements in the supporting documentation:

FOR MDD CLASS I STERILE devices: In particular ER 8

FOR MDD CLASS I MEASURING devices : In particular ER 10

The recommended format for the Essential Requirements Checklist is shown in the GHTF Document GHTF/SG1/N011:2008 (STED).

Manufacturers should include Reference to supporting controlled documents - this column should contain the reference to the actual technical documentation that demonstrates conformity to the essential requirement(s), i.e. the certificates, test reports, validation reports, study reports or other documents that resulted from the method used to demonstrate conformity and its location within the Technical File/Design Dossier.

For Class I Sterile &/or Measuring devices, please go to Question #3 below.

Is the conformity assessment route Annex II Yes No

If “No” – please go to Question #3 below.

If “Yes” - please provide a design input/OUTPUT matrix or equivalent document which ensures there is specific reference to the design elements associated with this application and demonstrate how the design outputs meet the design inputs through design verification and validation – Document number

Are Harmonised Standards being used Yes No

If “No” please justify -

Please list the relevant Harmonised Standards in Table 3 below

Table 3 – Applicable Harmonised Standards List

Standard / Year / Full Compliance
Yes/No

FOR MDD CLASS I STERILE devices: In particular Harmonised Standards relating to sterility

FOR MDD CLASS I MEASURING devices: In particular Harmonised Standards relating to the measuring function.

NSAI REVIEW

Class I Sterile

ER 8 adequately addressed -

Harmonised Standards for Sterilisation -

Class I Measuring

ER 10 adequately addressed -

Harmonised Standard(s) for Measuring -

Other classes of MDD devices & AIMDs