Medical Devices 
Significant Change Application Form
-	Class 1 Sterile
-	Class 1 Measuring 
-	Class 1 Sterile & Measuring

Submission Details
Please tick all that apply:
	Class 1 Sterile			
	Class 1 Measuring			
	Class 1 Sterile & Measuring			
	Transfer (from another NB)		Modular (partial application)	
	Fast Track (expedited)			
	
PO Number	     	
	
Directive(s) that apply:	NSAI File Number	
	MDD (93/42/EEC)		252.     /     	
	
If OBLs apply to this product, please state the relevant product families below:	
     /     ;      /     ;      /     	

Legal Manufacturer’s Name		
Legal Manufacturer’s Address		

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

2.	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.

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

4.	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 http://www.nsaiinc.com/ 

5.	Supporting documents should be in SEARCHABLE format

6.	Applications and supporting documentation must be in English

7.	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.

Table of Contents

SIGNIFICANT CHANGE APPLICATION FORM
Instructions
Applicants’ Submission Checklist
Declaration(S) By Applicant
Section 1: Manufacturer And Product Details
Section 2:  Nature Of The Change
Section 3:  Intended Use Of The Device
Section 4:  Labelling And IFU
Section 5:  Solutions To Essential Requirements
And Harmonised Standards
Section 6:  Risk Management
Section 7:  Sterilisation
7.1  Sterilisation
7.2  Maintenance Of Sterility Over Shelf Life
Section 8:  Measuring Function

APPLICANTS’ SUBMISSION CHECKLIST	
	Completed application form (Word format, .doc or .docx) 	
	Application (min. Signed Declaration page(s)) scanned	
	QMS certificates for any sites in Table 1 	
	(Draft) Declaration of Conformity	
	(Draft) Labelling & IFU	
	Essential Requirements Checklist	
	Performance/Complaint Analysis	
	Risk Management documentation	
	Sterilisation Validation(s) if provided sterile	
	Packaging & device Stability data 	
For Transfers	
	Copy of existing Notified Body Certificate(s)	
	Transition Plan	
	Contact details for existing Notified Body, including formal permission to contact existing Notified Body.	
(NSAI will not contact the existing Notified Body 
prior to agreement with the Manufacturer)	

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 provide all vigilance reports to the Competent Authorities and NSAI 
•	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.
•	We authorize and agree to allow NSAI access to all critical subcontractors and crucial suppliers, and all sites where the device or it’s crucial components are produced.   
•	We agree to allow NSAI access to the Legal Manufacturer’s premises, and /or any of the above listed sites at any time for the purposes of performing unannounced audits.
•	As necessary we agree to provide all necessary support in acquiring the necessary travel papers, including VISA, to facilitate NSAI access to the above listed locations.
•	We agree to inform NSAI of the periods when the devices identified in this application will not be manufactured. 
•	We understand that NSAI may end this contract with the Legal Manufacturer if permanent unannounced access to the above listed sites is no longer assured.
•	We understand that NSAI may cancel any unannounced audit at any time if the safety and security of NSAI personnel cannot be assured.	

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:		

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 www.gmdnagency.com	
	Declaration of Conformity included - Location within submission : 		
MDD ONLY:	
Class		Is		Im	Rule(s)		
Rationale	

Conformity Assessment	Annex		II		V (+VII)		VI	
	Full QA	Prodn QA	Product QA	
Date of this application
(i.e. date of Declaration of Applicant):		

SECTION 2:  NATURE OF THE CHANGE	
1.	Please provide a clear, detailed description of the change(s):	

	
2.	Did the change(s) arise from a vigilance or performance issue		Yes		No	
	If “Yes” – please advise: 		
3.	Has NSAI received the Vigilance Report(s)		Yes		No	
	If “Yes” – please advise:  		
	If “No” please:	
	a.	Justify: 		
	b.	If applicable, please submit a copy of the Competent Authority report(s) along with the completed NSAI Vigilance Form located at [http://www.nsaiinc.com/services/MedicalDevice -“Vigilance Reporting”] to vigilance@nsai.ie
	
4.	Has this product been the subject of product recalls or Incident Reports in other Regulatory geographies outside EU? If yes, please summarize and provide details with supporting documentation.	

	
5.	For those failure modes associated with the identified Root Causes, please clarify if the Occurrence Rates outlined in the Risk Management File required an update based on the observed real world rates.	

	

Section 3:  Intended Use of the Device	
1.	Is there a change in Intended Use		Yes		No	
2.	Please enter a full description of the revised intended use and/or indications for use of the device:	

	
3.	Does this change impact the classification rule:		Yes		No	
	If “No” please justify:		

Section 4:  Labelling and IFU	
1.	Is there a change to the Labelling/IFU		Yes		No	
Please supply a sample of the revised draft labelling & IFU in English	
2.	Location of the sample Label(s) & IFU in the supporting documentation	
3.	Please clarify the exact nature of change(s) to the labelling/IFU based on the proposed change(s) under review	

4.	Are the requirements of EN 980 & EN 1041 being met		Yes		No	
	Version of Standard :	

Section 5:  Solutions to Essential Requirements
                     and Harmonised Standards	
Please indicate how relevant Essential Requirements (Annex I) of the Directive are met for the proposed changes.	
1.	Location of the revised solutions to Essential Requirements in the supporting documentation 	
	FOR CLASS I STERILE devices: In particular ER 8
	
	FOR CLASS I MEASURING devices: In particular ER 10	
2.	Please list the relevant revised/updated Harmonised Standards in Table 2 below	
	
TABLE 2 – Applicable Harmonised Standards List	

Standard	
Year	
Has the Standard been applied in full
Yes / No	

	

	

	

	

	

	

	

	

	

Section 6:  Risk Management	
1.	Did the proposed change affect or change any existing risks		Yes		No	
	If “no” please justify:		

2.	Did the proposed change introduce any new risks		Yes		No	
	If “no” please justify:	

3.	Was the Risk documented
(e.g. during change control process, update to FMEA, memo to file etc.)		Yes		No	
	If “no” please justify:	

4.	If no update to Risk Management File, please provide rationale:	

	

Section 7:  Sterilisation	

7.1  Sterilisation	
1.	Does the proposed change affect sterilisation		Yes		No	
	If “no” please justify:		

2.	Is a full validation/revalidation required		Yes		No	

3.	If a full validation/revalidation is not completed, please provide an Adoption Justification / Rationale Report -	
	
Table 3 – Sterilisation Information Summary for Changes	

Device
sub-family	
Cat.
Number	
Sterilisation Method	
Sterilisation Location	
Protocol / Report No.	
Site Resp for Release	

	

	

	

	

	

	

	

	

	

	

	

	

	

	1.	Is EtO used for Sterilisation of the device(s)
If “No” please go to Question #2  below.		Yes		No	
		Is compliance with EN ISO 10993-7 latest version claimed			Yes		No	
		If “No” please explain		
		Is compliance with EN ISO 11135  latest version claimed			Yes		No	
		If “No” please explain		
		Please categorise the device according to the duration of contact	
			A – Limited Exposure	
			B – Prolonged Exposure	
			C – Permanent Contact	

	2.	Is irradiation used for Sterilisation of the device(s)  
If “No” please go to Question #3 below.		Yes		No	
		a.	Is compliance with EN ISO 11137  latest version claimed		Yes		No	
			If “No” please explain:		
				Gamma 		E-Beam	
		b.	What Dose setting method(s) are used	
				VDMAX25		Method 1		Method 2	
	3	Is moist heat used for Sterilisation of the device(s)  
If “No” please go to Question #4 below.		Yes		No	
		Is compliance with EN ISO 11138 latest version claimed		Yes		No	
		If “No” please explain		
		What cycle type used   		Pre-vac		Gravity		Other	
		Details if “Other” –		
	4.	If one of the above methods is not used, please describe the method – 
(e.g. Dry heat, Aseptic Fill, Liquid Chemical, etc.) and list the standard(s) applied		

Section 7:  Sterilisation	

7.2  Maintenance of Sterility over shelf life	
Does the change affect the products shelf life		Yes		No	
If “no” please justify:		
1.	Please define the shelf life/expiry date	      Years	
2.	Is the aging based on 		Accelerated		Real Time Data	
3.	Is compliance with EN ISO 11607 latest version claimed  		Yes		No	
	If “no” please justify:		
4.	Confirm start date of real time Packaging studies		
5.	Please list all relevant reports to justify the proposed change		
	Protocol #     
Report #       

Section 8:  Measuring Function	
1.	Does the proposed change affect the measuring function		Yes		No	
	If “no” please justify:		

2.	If yes provide copies of the updated validations