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Useful Advices - The ROLE of Non-European Manufacturers
This article is intended to provide you with a general understanding of your responsibility as a manufacturer. However, we recommend that you contact Obelis (O.E.A.R.C.) to walk you through these specific and detailed steps.
The following Products require Non-European Manufacturers to a
The following Products require Non-European Manufacturers to a
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ppoint a European Authorized Representative:
You only need Authorized Representative service You need both Notified Body and Authorized Representative services MDD Product CLASS I : non sterile devices CLASS I : sterile & measuring function device CLASS IIa
CLASS IIb
CLASS III
I
You only need Authorized Representative service You need both Notified Body and Authorized Representative services MDD Product CLASS I : non sterile devices CLASS I : sterile & measuring function device CLASS IIa
CLASS IIb
CLASS III
I
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
VD Product Self Declaration Products
SELF TESTING, ANNEX II or PERFORMANCE EVALUATION Products
THE FOLLOWING ARE STEPS YOU MUST TAKE TO PREPARE YOUR PRODUCT FOR SALE WITHIN EUROPE:
Appoint Obelis (O.E.A.R.C.) as your European Authorized Representative within the EU Territory. In ord
SELF TESTING, ANNEX II or PERFORMANCE EVALUATION Products
THE FOLLOWING ARE STEPS YOU MUST TAKE TO PREPARE YOUR PRODUCT FOR SALE WITHIN EUROPE:
Appoint Obelis (O.E.A.R.C.) as your European Authorized Representative within the EU Territory. In ord
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
r to apply for CE marking, you must appoint a "European Authorized Representative", which means a person established within the European Community or in a State which is Party to an Association Agreement who, explicitly designated by the manufacturer, act for the manufacturer and may be
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
addressed by the authorities and bodies in the Community instead of the manufacturer. Obelis (O.E.A.R.C.) provides superior quality European Authorized Representative Services, click here for details.
Assess your product according to the essential requirements in the Directives.(directi
Assess your product according to the essential requirements in the Directives.(directi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e library).
Identify the appropriate conformity assessment module according to your product classification. (MDD modules or IVD route).
Prepare a product Technical File, including a product user manual, as outlined in the Directive Annex below.
Determine the applicable Standards - Eur
Identify the appropriate conformity assessment module according to your product classification. (MDD modules or IVD route).
Prepare a product Technical File, including a product user manual, as outlined in the Directive Annex below.
Determine the applicable Standards - Eur
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
opean, International or National (applicable standard link).
If required, choose a Notified Body to perform the official conformity assessments tasks in accordance with procedures in the Directives. (MDD Notified Bodies, IVD Notified Bodies).
A Notified Body plays an important role in
If required, choose a Notified Body to perform the official conformity assessments tasks in accordance with procedures in the Directives. (MDD Notified Bodies, IVD Notified Bodies).
A Notified Body plays an important role in
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
he procedure for obtaining a CE marking for devices in classes IIa, IIb and III and for class I products placed on the market in sterile condition and/or with a measuring function. The notified body is a certification organization designated by the national authority of any EC country, w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hich is authorized to conduct conformity assessments in accordance with the procedures in the directive. The notified body offers its services to the manufacturer with the aim to have the manufacturer's product put on the European market in conformity with the directives. The notified bo
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
y performs its activities in a competent, neutral, independent and non-discriminatory manner. The European Commission assigned an identification number to each designated notified body.
The management will create a "vendor's endorsement"
EC Declaration of Conformity and contents of Tec
The management will create a "vendor's endorsement"
EC Declaration of Conformity and contents of Tec
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
hnical File
MDD 93/42/ECC Annex VIII
IVD 98/79/EC Annex III
Technical File must include:
1. a general description of the product
2. design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc. with explanations
3.
MDD 93/42/ECC Annex VIII
IVD 98/79/EC Annex III
Technical File must include:
1. a general description of the product
2. design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc. with explanations
3.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the results of the risk analysis
4. the results of the design calculations and of the inspections carried out, etc
5. the test reports and, where appropriate, clinical data
6. the label and instructions for the use
It is important to note that this is only a partial li
4. the results of the design calculations and of the inspections carried out, etc
5. the test reports and, where appropriate, clinical data
6. the label and instructions for the use
It is important to note that this is only a partial li
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t; there will be more requirements depending on which class your product falls into.
For selected types of devices, the European Authorized Representative must notify the product to the Competent Authorities(MDD class 1 and all IVD products)
Determine the proper Labeling method bas
For selected types of devices, the European Authorized Representative must notify the product to the Competent Authorities(MDD class 1 and all IVD products)
Determine the proper Labeling method bas
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ed on applicable directives.
Labeling & Instruction of use
MDD 93/42/ECC Article 4.4
MDD 93/42/ECC Annex I § 13.3
IVD 98/79/EC Annex I § 8
Assemble the required approvals and certificates and prepare an EC Declaration of Conformity per product according to the appli
Labeling & Instruction of use
MDD 93/42/ECC Article 4.4
MDD 93/42/ECC Annex I § 13.3
IVD 98/79/EC Annex I § 8
Assemble the required approvals and certificates and prepare an EC Declaration of Conformity per product according to the appli
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
able Directives.
EC Declaration of Conformity and contents of Technical File
MDD 93/42/ECC Annex VIII
IVD 98/79/EC Annex III
Affix the CE Marking in accordance with the European Directives.
The Manufacturer /European Authorized Representative must make the technical documen
EC Declaration of Conformity and contents of Technical File
MDD 93/42/ECC Annex VIII
IVD 98/79/EC Annex III
Affix the CE Marking in accordance with the European Directives.
The Manufacturer /European Authorized Representative must make the technical documen
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
tation, including the declaration of conformity, available to the European Authorities for inspection purposes, for at least five to ten years after the last product has been manufactured
The manufacturer must institute and keep up-to-date systematic procedures to review the exp
The manufacturer must institute and keep up-to-date systematic procedures to review the exp
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking into account the nature and risks in relation to the product.
Vigilance & Risk Analysis system MDD 93/42/ECC Annex VI
IVD 98/79/EC Ann
Vigilance & Risk Analysis system MDD 93/42/ECC Annex VI
IVD 98/79/EC Ann
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ex IV
The manufacturer must also immediately notify the European Competent Authorities (via the European Authorized Representative) of the following incidents:
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the l
The manufacturer must also immediately notify the European Competent Authorities (via the European Authorized Representative) of the following incidents:
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the l
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
beling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health;
Any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred i
Any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred i
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
n the Directive leading to systematic recall of devices of the same type by the manufacturer.
Note: If a ce approved product causes any of these incidences OUTSIDE the European Union, you must report such incidents to the European Authorities (via the European Authorized Representative)
Note: If a ce approved product causes any of these incidences OUTSIDE the European Union, you must report such incidents to the European Authorities (via the European Authorized Representative)
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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