Tags |
|
|
Links |
|
|
Actual - CE Marking Electronic Products
All electronic products sold within the European Union are required to be CE Marked. However I find that there is a large amount of confusion and misunderstanding, with
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
people struggling to find what is required of their product.
The legal responsibility for compliance with the CE mark remains with the company that either owns the manufacturing right
The legal responsibility for compliance with the CE mark remains with the company that either owns the manufacturing right
; 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
for the product, or imports it into the EU. It is not possible to "outsource" this legal responsibility to a third party. Test and compliance houses can provide third party validation
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
that a product has been produced and tested against the required standards. Test houses can also advise on the standards against a specific product should be tested, bear in mind that i
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
is ultimately you who has responsibility for compliance so some research and general understanding is advisable.
From the UK Department of Trade guidelines on CE marking a definition
From the UK Department of Trade guidelines on CE marking a definition
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
f for CE marking is "a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives".
Typi
Typi
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
cal areas covered by the legislation are EMC, EMI, Safety and Environmental laws.
EMC - The unwanted Electromagnetic energy generated by your product. There are normal
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
y limits for both conducted and radiated emissions.
EMI - The ability of your equipment to withstand electromagnetic interference from other sources without malfunctio
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ning or interrupting its normal operation.
ESD - Electrostatic Discharge testing involves testing the ability of your equipment to withstand the high voltages that occ
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
r when static discharges occur. A typical source of ESD is when a person walks on a carpet, generating a few thousand volts of potential.
Safety - Safety testing can c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ver the electrical, mechanical and fire related safety tests.
Environmental - The most well known environmental legislation is the RoHS directive cove
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
ring hazardous substances such as lead, however there is also the WEEE directive covering end of life disposal. An up coming piece of legislation is the Energy
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
sing Products directive which will come into force in the near future.
In addition to the areas outlined previously, some products such as wireless equipment are required to m
In addition to the areas outlined previously, some products such as wireless equipment are required to m
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
eet specific legislation, with testing required by an authorised body or so called "notified body". A common misconception is that ISM or so called "license free" radios do not require
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
ype approval testing - this is not true. As this testing can be expensive it is wise to research the costs prior to commencing a development, as it can effect the direction you take. Fo
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
example it is possible to buy pre-approved modules, removing the burden of type approvals.Equipment that does not require testing by a notified body can be self certified.
A "technica
A "technica
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
l construction file" should be created. The TCF contains all the technical details of the product, including assessments of legislative compliance with test reports from the appropriate
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
test houses or internal testing.
In addition to the legal requirements you may wish to or are contractually required to test and comply with industry or military standards, such USB, B
In addition to the legal requirements you may wish to or are contractually required to test and comply with industry or military standards, such USB, B
.
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
luetooth, IP ratings, MIL810 etc. It is important to remember that while these may add a level of credibility to a product they can incur large costs. In a similar manner to type approv
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
ls it is wise to get preliminary costing for the approvals phase. While these voluntary standards add credibility to a product, they will have an impact on the unit cost of your product
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.actual.org.ua/article/131230/actual-CE-Marking-Electronic-Products.html">CE Marking Electronic Products</a>
BB link (for phorums):
[url=http://www.actual.org.ua/article/131230/actual-CE-Marking-Electronic-Products.html]CE Marking Electronic Products[/url]
Related Articles:
Why You Should Be A Coach, Not Just A Manager
Bookmark it:
|