Digg It - Business

Sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the European market's substantial global market share. Estimated at 30% of the global medical device market, the European community poses increasing regulatory challenges for medical device manufacturers. Regulations controlling the manufacturing, marketing and usage of medical devices in the EU are forcing manufacturers to incorporate language translation and localization into global development strategies as individual Member States demand product information in the language of the local user.

An exigent regulatory hurdle facing the medical device industry is the European U

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

nion's IVDD 98/79/EC directive which went into effect December 7, 2003. Formulated five years ago, the IVDD 98/79/EC dictates that as of the December date, all new in vitro medical devices must bear CE Marks or face refusal into the European market or regulatory, criminal or product/civil liability.

What is the guiding principle behind the new directive?

The IVDD Directive virtually eliminates the costly regulations imposed by individual member states. Manufacturers who comply with the Directive will be able to apply the CE mark to their products and market them freely within member states of the EU. The IVDD (In Vitro Diagnostic Devices Directive) is one of three associated directives iss

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ued by the European Union, which together cover all forms of medical equipment with the intent to ensure that only safe and effective products are sold in the European market. The directives clearly outline regulations regarding manufacturing, importing, and marketing of such devices. The IVDD specifically involves in vitro ( in an artificial environment outside the living organism ) medical devices that examine human fluids or tissue samples to identify, diagnose, and monitor medical conditions. The IVDD 98/79/EC brings in vitro devices in line with other medical devices already regulated by the EU, the MDD (Medical Devices Directive) and the AIMDD (Active Implantable Medical Devices Directiv

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e).

The IVDD and it sibling directives apply progressive regulatory requirements to medical devices and their accessories depending on the classified risk they present to the user, defined in the directive as Class I through III. Unless the classified product is a low-risk Class I device that does not contain any sterile packaging or a measuring function, manufacturers require a third-party Notified Body to independently certify the device's compliance to the Directive's Essential Requirements (a.k.a. Annex I)-good faith is not enough. Additionally, in a new twist within the Directive, the authorized representative shown on the device label for Class I devices manufactured outside the EU may

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

be required to produce the technical file, including copies of all translated materials. Any incorrect labeling or instructions for use may lead to regulatory criminal or product/civil liability in the EU.

Any medical device manufacturer wishing to market its products in the European Union is fully responsible for complying with the corresponding safety and administrative Essential Requirements and must display the CE mark of conformity as stated in Article 16 of the IVDD 98/79/EC . If that's not a red flag, consider the next regulatory deadline facing in vitro device manufacturers: By December 7, 2005, the European Union will not only require a CE mark to legally market a product, but will r

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

quire a CE mark to legally put a medical device into service—a requirement much more critical to the revenue of manufacturers and healthcare!

CE Mark: A passport to the European Union
An abbreviation of a French phase "Conformite Europeene," the CE mark indicates that the medical device manufacturer has conformed to all the obligations set forth by the Directive 98/79/EC of the European Parliament. Affixing this multinational standardized mark to a product will allow any global manufacturer a "passport" to freely distribute their products within the European Union without additional quality testing or approvals. Reflective of the 1946 Treaty of Rome, the CE mark is a conformity tool that

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

is intended to further promote the establishment of a single market where the free movement of goods, persons, services and capital are ensured. Fundamentally, the CE mark and the medical device directives remove many regulatory hurdles while providing stronger regulations for smaller countries; however, it also creates critical language compliance issues that may prove to be costly for manufacturers. Regardless of the intended global harmonization, participating countries are preserving their national cultures and languages by requiring product information in their own local languages.

IVDD, MDD & AIMD…more languages!
Depending on device classification, to legally display the CE mark,

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

the IVDD, MDD, and AIMD all mandate that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user's Member State, taking into account the training and knowledge of the potential users as stated in Article 4, Paragraph 4, IVDD 98/79/EC .

Documentation Translation Requirements — Conformity Assessment Procedures Manufacturers are required to translate the documentation relating to the production, testing and quality processes in the official language(s) of the Member State in which the procedures are carried out as stated in Article 9, Paragraph 11 of the IVDD 98/79/EC. Depending on device classification, thes

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e documents must include a number of required disclosures dependent on the product classification. Depending on marketing and distribution objectives, some products may require up to 12 languages, creating complicated multilingual product labeling and IFU challenges. There can be over 20 information pieces required for each product label of IFU, depending on the classification as detailed in Annex I, Part B, Section 8 of the Directive.

Table I Official Language(s) of EU Member States

Member State Official language(s)

Austria - German

Belgium - Dutch, French & German

Denmark - Danish

Finland - Finnish

France - French

Germany - German

Greece - Gre

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

ek

Ireland - English

Italy - Italian

Luxembourg - French, German, Luxembourgish

Netherlands - Dutch

Portugal - Portuguese

Spain - Spanish

Sweden - Swedish

United Kingdom - English

Table II
Official Language(s) of EFTA Member States
Member State Official language(s)

Iceland - Icelandic

Liechtenstein - German

Norway - Norwegian

Switzerland - German, French & Italian

( Switzerland is not a EFTA member but requires translation)

Table III
Official Language(s) of Member States Applying For EU Membership
Member State Official language(s)

Bulgaria - Bulgarian

Cyprus - Greek

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

Czech Republic - Czech

Estonia - Estonian

Hungary - Hungarian

Latvia - Latvian

Lithuania - Lithuanian

Malta - English & Maltese

Poland - Polish

Romania - Romanian

Slovakia - Slovak

Slovenia - Slovenian

Turkey - Turkish

EU Member State Official Languages
Depending on the extent of the product's presence in the European Union, there are currently up to 12 languages required for the labeling, IFUs, documentation, and marketing materials in accordance with the IVDD and MDD necessary for CE mark as displayed in TABLE I .

As the EU continues to grow and the trading barriers dissolve, prospective Member States are acti

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

vely transitioning regulations to meet the CE mark criteria, requiring new languages. A midday regulatory shadow to the EU, European Free Trade Association (EFTA) countries of Iceland, Liechtenstein and Norway are aggressively enforcing the CE mark, shown in TABLE II . Although not a member of the EFTA, Switzerland is also enforcing medical device CE mark.

In addition to the EFTA, 13 more countries have applied for membership in the European Union. Performing a parallel migration to the European Union's regulatory requirements, several of these future Member States are actively adopting the CE Mark to ensure goods can freely move throughout the European Union, including Poland, Romania, Slova

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

kia, and Turkey, see

TABLE III .
Global Harmonization and International Quality Standards In 1998, the United States and the European Union introduced the New Transatlantic Agreement (NTA) to improve economic cooperation between the two economic powers. In this landmark accord resides the Mutual Recognition Agreement (MRA) that acknowledges the regulatory standards of the respective economic bodies-an area of transition that affects the medical device industry. The European Union medical device directives refer to ISO 9001 as the series of quality management standards and the US refers to FDA's Quality System Requirements and all corresponding good manufacturing (GMP) practices regulat

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ions. Benefiting medical and pharmaceutical companies, both quality systems have made considerable efforts to synchronize their requirements further increasing the common ground between quality systems in North America and Europe.

ISO (International Organization for Standardization) Adding to the pressure the current ISO 9000:1994 standard is transitioning to a new ISO: 9000:2000 series effective December 14th of this year. However, as of May 15, 2003, only 19.5% of the total ISO registered North American companies had completed their registration process. This is essential in the entire chain of requirements. The new standard is a consolidation of ISO 9001 and 9002, and has more of a custom

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

er satisfaction and continuous improvement focus not present in previous versions.

GMP (Good Manufacturing Practices)
In December 1978, the FDA Good Manufacturing Practices (GMP) Regulation became effective, establishing Quality System Requirements for products regulated under the FDA, including medical devices. In 1990, the Safe Medical Devices Act (SMDA) expanded the GMP to include design, manufacturing, packaging, labeling, storage, installation and servicing of all finished medical devices.

Exporting American Medical Devices
Any medical device in the US market may not be legally exported anywhere in the world without prior FDA notification or approval; however, for a device to

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

e legally distributed in the US, the FDA requires: Registration of both the medical device and manufacturing site

- Authorization for commercial distribution through either a 510(k) pre-market notification or a Pre-market Approval (PMA) application depending upon the classification of the device

- Compliance with FDA labeling requirements

- Manufacturing compliance with the FDA's Good

Manufacturing Practices (GMP)

While the FDA does not place any restrictions on the export of these devices, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations. Medical devices that do not have a 510(k), PMA, or are solely manu

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

factured for export may by approved for exportation by the FDA through Section 801(e)(1) of the FFDCA; however, the manufacturer may experience regulatory difficulties depending on the individual country's requirements of an FDA Export Certificate, which, as stated above, require a 510 (k) or a PMA.

Sorting through the regulations to achieve global product delivery The question facing medical device manufacturers in the current global market is how to meet all language requirements in the most cost-effective, regulatory compliant manner. Managing regulations and translations are among the most critical aspects of developing and marketing products for the life sciences industries. Any mistak

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. Therefore, developing translation and localization processes has become a competitive advantage for global manufacturers of medical devices.

Working closely with a translation and localization vendor who specializes in medical language services is an important step in conquering the ever-changing international regulatory process. The choice of the translation provider is extremely important to ensure that translations are accurate, consistent and technically correct, as well as harmonious with the manufacturers' processes.

Medical language service providers should—at the very least—

.

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

provide documented processes that involve native-speaking linguists that have expertise in both medical translation and the medical industry. To deliver consistency, quality and reduced costs, the language service provider should also implement terminology management tools and computer-assisted translation solutions in concert with the team of human translators.

Conclusion
Complex and ever-changing international regulations controlling the marketing and usage of medical devices are forcing manufacturers to incorporate language translation and localization into global development strategies. The European Union members currently require that all product information be in the official langu

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

age of the local users and the diversity of this economic area is only growing to include more regulations and official languages. A simultaneous global release of medical devices involving up to 12 languages in Europe alone makes this issue as critical as the intended purpose of the medical device. Medical device manufacturers can cost-effectively market their products globally while satisfying international regulatory requirements by partnering with Net-Translators a qualified language service provider in the very early stages of product development. The right language partner can turn what may now appear as a chaos of regulatory requirements into a successful international product release

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.diggit.org.ua/article/28327/diggit-European-Regulatory-Language-Requirements.html">European Regulatory Language Requirements</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/28327/diggit-European-Regulatory-Language-Requirements.html]European Regulatory Language Requirements[/url]

When jobs of high caliber, such as COO, CEO and President, are vacated, there are many qualities to be considered in an applicant, qualities such as capability, experience, and education. But the quality that is most likely to facilitate acquiring such lucrative positions, and there's no doubt about it among the experts, is that part of some personalities called charisma.

Promotional gifts serve your company in many different ways, and the items that you choose as giveaways should reflect their purpose. One important way that you can use promotional gifts is in prospecting for new clients.

Marketing your small business is easy. And, you don’t have to break the budget to do it. Just follow these four keys and you're on your way!

Tags

Links

Digg It - European Regulatory Language Requirements

Related Articles: