B. QUALITY CHANGES – B.IV Medical Devices (obsolete version)

B.IV.1 Change of a measuring or administration device	Conditions to be fulfilled	Documentation to be supplied	Procedure type
a) Addition or replacement of a device which is not an integrated part of the primary packaging
1. Device with CE marking	1, 2, 3, 6, 7	1, 2, 4	IA_IN
2. Device without CE marking for veterinary products only		1, 3, 4	IB
3. Spacer device for metered dose inhalers or other device which may have a significant impact on the delivery of the active substance in the product (e.g. nebuliser)			II
b) Deletion of a device	4, 5	1, 5	IA_IN
c) Addition or replacement of a device which is an integrated part of the primary packaging			II
Conditions
1. The proposed measuring or administration device must accurately deliver the required dose for the product concerned in line with the approved posology and results of such studies should be available.
2. The new device is compatible with the medicinal product.
3. The change should not lead to substantial amendments of the product information.
4. The medicinal product can still be accurately delivered.
5. For veterinary medicinal products, the device is not crucial for the safety of the person administering the product.
6. The medical device is not used as a solvent of the medicinal product.
7. If a measuring function is intended the CE marking should cover the measuring function.
Documentation
1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including description, detailed drawing and composition of the device material and supplier where appropriate, and including revised product information as appropriate.
2. Proof of CE marking and if a measuring function is intended the proof of CE marking should also include the 4 digit notified body number.
3. Data to demonstrate accuracy, precision and compatibility of the device.
4. Samples of the new device where applicable (see NTA, Requirements for samples in the Member States).
5. Justification for the deletion of the device.
Note: For B.IV.1.c), applicants are reminded that any change which results in a “new pharmaceutical form” requires the submission of an Extension application.

#biv2

B.IV.2 Change in specification parameters and/or limits of a measuring or administration device for veterinary medicinal products	Conditions to be fulfilled	Documentation to be supplied	Procedure type
a) Tightening of specification limits	1, 2, 3, 4	1, 2	IA
b) Addition of a new specification parameter to the specification with its corresponding test method	1, 2, 5	1, 2, 3, 4, 6	IA
c) Widening of the approved specifications limits, which has a significant effect on the overall quality of the device			II
d) Deletion of a specification parameter that has a significant effect on the overall quality of the device			II
e) Addition of a specification parameter as a result of a safety or quality issue		1, 2, 3, 4, 6	IB
f) Deletion of a non-significant specification parameter (e.g. deletion of an obsolete parameter)	1, 2	1, 2, 5	IA
Conditions
1. The change is not a consequence of any commitment from previous assessments to review specification limits (e.g. made during the procedure for the marketing authorisation application or a type II variation procedure) unless the supporting documentation has been already assessed and approved within another procedure.
2. The change should not be the result of unexpected events arising during manufacture.
3. Any change should be within the range of currently approved limits.
4. The test procedure remains the same
5. Any new test method does not concern a novel non-standard technique or a standard technique used in a novel way.
Documentation
1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate).
2. Comparative table of current and proposed specifications.
3. Details of any new analytical method and summary of validation data.
4. Batch analysis data on two production batches for all tests in the new specification.
5. Justification/risk assessment showing that the parameter is non-significant based or that it is obsolete.
6. Justification for the new specification parameter and the limits

#biv3

B.IV.3 Change in test procedure of a measuring or administration device for veterinary medicinal products	Conditions to be fulfilled	Documentation to be supplied	Procedure type
a) Minor change to an approved test procedure	1, 2	1, 2	IA
b) Other changes to a test procedure (including replacement or addition)	1, 3	1, 2	IA
c) Deletion of a test procedure if an alternative test procedure is already authorised	4	1	IA
Conditions
1. Appropriate validation studies have been performed in accordance with the relevant guidelines and show that the updated test procedure is at least equivalent to the former test procedure.
2. The method of analysis should remain the same.
3. Any new test method does not concern a novel non-standard technique or a standard technique used in a novel way
4. An alternative test procedure is already authorised for the specification parameter and this procedure has not been added through IA/IA(IN) notification.
Documentation
1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate, including a description of the analytical methodology and a summary of validation data.
2. Comparative validation results or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.