If you export to Europe, you will certainly be interested in learning about some important changes that are being proposed for the Medical Device Directive 93/42/EEC (MDD), plus some changes that will also impact the Active Implantable Medical Device Directive. The European Commission recently released the latest and final recommendations for changes to the MDD. While the reforms fall short of what some had hoped for, there are significant changes nonetheless, and regardless of what type of device you manufacture, you should be aware of them. Summary of Changes Made by Directive 2007-47-EC Following are some of the more important changes that will take place once the recommendations are adopted.

The Commission Draft Proposal, released December 22, 2005, recommends the following: Active implantables - The Active Implantables Medical Device Directive 90/385/EEC was adopted in 1990, before the MDD and IVDD. Important updates have been made that make it more coherent with the MDD 93/42/EEC, including references to the, European databank, health protection and the application of Directive 2000/70/EC concerning devices incorporating stable derivatives of human blood or plasma. Authorized Representative (AR) - Appointment of an AR for all classes of devices is now explicitly noted. The AR gets an explicit mandate to act, and be contacted, in lieu of the manufacturer in terms of meeting the obligations by the Directives. Borderline products - Whether a product is a drug or device will be determined by the Primary Mode of Action rather than by the Intended Use! If you manufacture a product that could be classified as a drug or device, be sure to read the official EU Guidance document MEDDEV 2.1/3 Rev 2 from July 2001. Central circulatory system - This now includes the vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae).

Any devices that come in contact with these vessels will now be considered Class III. Clinical data - All devices now require these data, including Class I devices. Also, this imposes more stringent requirements as to what constitutes 'clinical evidence' and mandates stronger enforcement by authorities. Annex X on Clinical Evaluations has been significantly amended. Combination devices - If a medicinal product, as defined in Article 1 of Directive 2001/83/EC, is used in such a way that the device and medicinal product form a single integral product which is intended solely for use in the given combination and which is not reusable, that single produce shall be governed by Directive 2001/83/EEC.

Annex I of this Directive will govern safety and performance. Conformity assessment - Class I Sterile and Measuring devices now have more flexibility to select a route to compliance, as they will be given the option to select a full quality assurance conformity assessment module. See Annex II of the MDD. Definition of 'continuous use' - This now includes situations in which a device, upon discontinuation or removal, is replaced immediately by the same or with an identical device.

E-Labeling - A provision has been made that opens the door for Instructions for Use to be delivered through electronic media instead of the 'leaflet' format currently noted. This would be especially useful for companies that sell in many EU countries because it could potentially allow them to pass along the IFU on a CD or via other electronic means, eliminating the many different paper versions now required. Ergonomics ('human factors') - Both in terms of the Essential Requirements (Annex I) and in terms of labeling, the user is now considered a key factor.

EU medical devices agency - The final proposal does not call for the creation of a pan-European devices agency similar to the US FDA. European databank - Data related to clinical investigations will now be collected for the European databank and shared among Competent Authorities. The databank will also include information on registration, Authorized Representative, certificates and vigilance data. The data must be submitted in a standardized format, yet to be determined.

At this time, the European databank is not operational. Human tissue - Devices that incorporate human tissue, blood or plasma will fall within the scope of Directive 2001/83/EC and be considered Class III. Many changes are included in this section, and companies that have these products should review the final draft proposal carefully. Increased transparency - Certain non-confidential summary information on devices will now be publicly available. Manufacturers of Class IIb and Class III devices will be required to submit a summary of information and data related to the device.

Approximation of the laws of the Member States relating to cosmetic products, and Commission Directive. Commission Directive 83/496. Commission Directive 90.

In Vitro Diagnostics - IVDs are now specifically excluded from Directive 98/8/EC on Biocides, eliminating confusion as to which Directive applies. Outsourced design and manufacturing - If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of the party's quality system.

This can, of course, be achieved through audits, receiving inspections or other means. Notified Bodies - These will be required to perform an inspection of design documentation for a representative sample of devices using industry standard statistical techniques and 'commensurate' with the risk of the device. Post market surveillance- Custom devices will now require a post-market surveillance system that is reportable to Competent Authorities. Records retention - Records must now be maintained for inspection by the Competent Authorities for the 'useful life of the product' or five years from date of manufacture, whichever is greater. The former rules indicated that you must maintain records for a period of five years but did not specify 'from date of manufacture.'

If you have never established a 'useful life' for your product, you should do so. Reusable surgical instruments - In earlier drafts, the Commission recommended that these products and other surgically invasive devices for transient use be moved to Class IIa. They will, however, remain Class I devices.

The proposed changes had a lot of people up in arms and, in the end, the Commission realized that strengthening their classification was not commensurate with the risk posed to the public. Software - This will now be considered an active medical device, whether integral with the device or as a stand-alone product. Software validation will also be an Essential Requirement in Annex I. This is a very high level summary of the most common changes. You may want to review the many other changes to the MDD not described here. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries.

This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.

A sample nutrition facts label, with instructions from the U.S. Food and Drug Administration. The nutrition facts label (also known as the nutrition information panel, and other slight variations) is a label required on most in many countries. Updates can be infrequent. For example, the United States established rules for Nutrition Facts panel in 1990 and did not revise those rules until 2016.

Most countries also release overall for general educational purposes. In some cases, the guides are based on different dietary targets for various nutrients than the labels on specific foods. Contents • • • • • • • • • • • • • • Australia and New Zealand [ ] Australia and New Zealand use a nutritional information panel of the following format: NUTRITION INFORMATION Servings per package: Serving size: g Quantity per Serving Quantity per 100 g Energy 0 kJ (Cal) Protein 0 g Fat, total 0 g - saturated 0 g Carbohydrate g g - sugars g g Sodium mg mg Other items are included as appropriate, and the units may be varied as appropriate (e.g. Substituting ml for g, or mmol for mg in the 'Sodium' row). In April 2013 the New Zealand government introduced rules around common claims made on food packaging, such as 'low in fat'. A Canadian Nutrition Label displaying information in both English and French. In, a standardized 'Nutrition Facts' label was introduced as part of regulations passed in 2003, and became mandatory for most prepackaged food products on December 12, 2005.

(Smaller businesses were given until December 12, 2007 to make the information available.). In accordance with food packaging laws in the country, all information, including the nutrition label, must be written in both English and French, the country's two official languages. Canadian regulation tightly controls the manner in which the nutrition fact table (NFT) data are laid out. There is a wide variety of possible formats for use on a given food package. A selection hierarchy is used to select among the many formats (28 main formats, and 2-7 sub formats for each). This results in standard (vertical) formats being considered for use before horizontal and linear formats.

The selection hierarchy also allows the NFT to occupy no more than 15% of the physical package's available display area (ADS), but never to be smaller than a format that would be. A rare example of optional nutrition facts on a label for oranges (in the EU not mandatory for unprocessed fruits) It was regulated by the Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for as regards recommended daily allowances, and definitions. A new regulation is now in force (Regulation 1169/2011).

Nutritional labelling becomes mandatory for most pre-packaged foods as from December 2016. In the European Union, along the 'old' rules (Directive 90/496, amended), the information (usually in panel format) is most often labelled 'Nutrition Information' (or equivalent in other EU languages). An example is shown on the right.

The panel is optional, but if provided, the prescribed content and format must be followed. It will always give values for a set quantity — 100 g (3.5 oz) or 100 ml (3.5 imp fl oz; 3.4 US fl oz) of the product — and often also for a defined 'serving', as an option. First will come the energy values, in both and. Then will come a breakdown of constituent elements: usually most or all of protein, carbohydrate, starch, sugar, fat, fibre and sodium. The 'fat' figure is likely to be further broken down into and unsaturated fat, while the 'carbohydrate' figure is likely to give a subtotal for sugars. With the 'new' rules, the mandatory information is: energy, fat, saturates, carbohydrates, sugars, protein and salt, in that particular order, with options to extend this list to: mono-unsaturates, polyunsaturates, polyols, starch, fibre, and vitamins and minerals. With regards to health claims and nutrition (composition) claims, these are harmonised in the EU through Regulation 1924/2006, amended.

In November 2012, the European Commission published two new regulations: Regulation (EC) No. 1047/2012 and Regulation (EC) No.1048/2012. Certain nutrition claim groups as of Regulation (EC) No 1924/2006 had to be changed. Moreover, the health claims associated to barley beta-gluten were amended (e.g. Lowering blood cholesterol). Within Regulation 1924, there are legal definitions of terms such as 'low fat', 'high fibre', 'reduced calories'. All health claims have been harmonised in the European Union.

They can be used if they have been approved. The list of approved and rejected claims is available on a web site. Provided the full nutrition information is shown on the packet, additional nutritional information and formats (e.g. A ) may be included and this falls outside the scope of regulation.

The United Kingdom regulations are given in Schedules 6 and 7 of the Food Labelling Regulations 1996. The new Nutrition Facts label The label was mandated for most food products under the provisions of the 1990 (NLEA), per the recommendations of the U.S.. It was one of several controversial actions taken during the tenure of FDA Commissioner.

The law required food companies to begin using the new food label on packaged foods beginning May 8, 1994. (Meat and poultry products were not covered by NLEA, though the U.S.

Department of Agriculture proposed similar regulations for voluntary labeling of raw meat and poultry. ) Foods labeled before that day could use the old label. This appeared on all products in 1995. The old label was titled 'Nutrition Information Per Serving' or simply, 'Nutrition Information'. The label begins with a standard measurement, are listed second, and then following is a breakdown of the constituent elements. Always listed are,, and; the other nutrients usually shown may be suppressed, if they are zero.

Usually all 15 nutrients are shown:, calories from fat,,,,,,,,,,,,, and. Products containing less than 5 g of fat show amounts rounded to the nearest 0.5 g. Amounts less than 0.5 g are rounded to 0 g. For example, if a product contains 0.45 g of trans fat per serving, and the package contains 18 servings, the label would show 0 g of trans fat, even though the product actually contains a total of 8.1 g of trans fat.

In addition to the nutrition label, products may display certain nutrition information or health claims on packaging. These health claims are only allowed by the FDA for 'eight diet and health relationships based on proven scientific evidence', including: calcium and osteoporosis, fiber-containing grain products, fruits and vegetables and cancer, fruits, vegetables, and grain products that contain fiber—particularly soluble fiber—and the risk of coronary heart disease, fat and cancer, saturated fat and cholesterol and coronary heart disease, sodium and hypertension, and folate and neural tube defects. The Institute of Medicine recommended these labels contain the most useful nutritional information for consumers: saturated fats, trans fats, sodium, calories, and serving size. In January 2011, food manufacturers and grocery stores announced plans to display some of this nutrition information on processed food.

The nutrition facts label currently appears on more than 6.5 billion food packages. President issued an award of design excellence for the nutrition facts label in 1997 to in Washington, DC. The FDA does not require any specific typeface be used in the Nutrition Facts label, mandating only that the label 'utilize a single easy-to-read type style', though its example label uses. However, as regulated by the FDA and the USDA, it is mandatory for certain information listed in the label to be written in English, including: name of the product, net quantity, serving size and number of servings per package, nutrition facts, ingredient list, and name of manufacturer or distributor.

The smallest lettering should be at least 1/16th of an inch tall (1.5875 millimeters), based on the height of a lowercase 'o'. In 2009, a federal appellate court rejected the New York State Restaurant Association’s challenge to the city’s 2007 regulation requiring most major fast-food and chain restaurants to prominently display calorie information on their menus. The rule applies to restaurants that are part of chains with at least 15 establishments doing business nationally. Are under the jurisdiction of the (TTB), and as of 2012 are not required to have a nutrition facts label.

Since at least 2003, consumer groups have lobbied the TTB to require labelling disclosing relevant information. Marketing terms such as 'light' for beers and wines, and 'table wine' do have specific requirements, and in certain cases alcohol content must be disclosed. In January 2006, Trans fat was required to be listed under saturated fat. This was the first significant change to the Nutrition Facts panel since it was introduced in 1993.

Revision to Nutrition Facts panel [ ] In 2014, the U.S. Food and Drug Administration proposed several simultaneous improvements to nutrition labeling for the first time in over 20 years. The proposed changes were based on trends of consumption of nutrients of public health importance. However, studies had shown that the majority of the U.S. Population could not understand the information in the then current Nutrition Facts Label.

Nutrition label numeracy is particularly low in older individuals, of black and Hispanic race/ethnicity, who are unemployed, born outside of the US, have lower English proficiency, lower education achievement, lower income, or live in the South. Proposed changes included a new design requiring serving sizes to more accurately reflect how many servings the average individual is actually consuming. The new recommendation also proposed removing “calories from fat”, and instead focusing on total calories and type of fats being consumed in a product. The proposed labels were to also list how much sugar is added (rather than inherent) to a product, as well as declaring the amount of Vitamin D and potassium in a product.

Some of these changes sparked a major debate between the food industry and public health agencies. The proposal to indicate sugar added during food production, in particular, was brought forward by the FDA as a measure to counter the increase in per capita sugar consumption in the US, which over the last decades exceeded the limits recommended by scientific institutions and governmental agencies. Major American food associations opposed the label change, indicating 'lack of merit' and 'no preponderance of evidence' to justify the inclusion of sugar added in the new label. The rules for the new design were finalized on May 20, 2016. Manufacturers were initially given until July 26, 2018 to comply (or July 26, 2019 if they have less than $10 million in annual food sales).

A proposed rule by the FDA would extend the compliance deadline to January 1, 2020 (or January 1, 2021 for qualified small business). For food and dietary supplement labeling purposes the amounts of vitamins and nutritionally essential minerals in a serving are expressed as a percent of Daily Value (%DV). Many of the definitions of 100% Daily Value were changed as part of the revision. A table of the old and new adult Daily Values is provided. Misleading Nutrition Facts on Food Labels [ ] The FDA is constantly updating and changing its guidelines to help inform consumers and keep them safe from misleading labels. Food producers and their marketing techniques have continued to find ways to circumvent existing regulations. Of the many claims and misleading labels in question, the use of the label “Healthy” on a variety of foods has been a particular issue for many food quality advocacy groups.

In their comments to the FDA, The Center for Science in the Public Interest(CSPI) urged FDA officials to address the incongruity between current dietary recommendation/nutritional standards and their definition, CSPI argued that the current definition is too ambiguous and sets a low health standard that allows processed foods with minimal and low nutritional value to use this definition to entice consumers into making poor health choices. The CSPI claimed that the FDA’s current guidance on this issue could be potentially misleading and could incline customers to consume unhealthy foods without making informed decisions. CSPI and their research suggested that a new standard and more adequate definition should make it more difficult for processed food brands to obtain and misuse the “healthy” food label, ultimately giving consumers a better ability to make informed decisions based on the nutritional and health quality of the food they consume as opposed to relatively unsubstantiated claims. In addition to using the “healthy” food label to draw customers to low nutrition foods, food marketers have used a variety of “low content,” like low fat, low calorie, etc claims to assuage consumer’s health concerns and to potentially mislead them.

“Low content” claims are labels or other advertised claims that appear on packages and or in advertisements are used so that consumers perceive the products they buy as being healthier or more nutritious. Misleading food health assertions of this nature are both widespread in food marketing and and also not reflective of the actual nutritional or health quality of the food or beverage in question. These claims are not consistent among all food and beverage groups, although some of them do accurately represent the nutritional and or health benefits of a certain food or beverage, often this does not guarantee that all claims across all beverages and foods are reflective of actual nutrition.

Additionally, even if a certain product is in fact low fat or any one of the different types of “low content” claims, consumers often focus on the claim and neglect other health considerations like added sugars, calories, and other unhealthy ingredients. The Food industry constantly confuses consumers.

Some of the basic reasons why people are misled is because terms such as natural, non-GMO, trans-fat free, or kosher do not have consistent definitions for consumers to follow. Without clear standards or definitions, these claims are not informative of the true nutritional content of the food in question. Non-GMO products are often mistaken for organic, just because it is certified as non-GMO.

Conventionally raised crops like corn, canola, and soy may be certified non-GMO if they are grown without genetically engineered seeds. Many snack chips being sold in stores use non-GMO ingredients grown with chemical pesticides. Non-GMO does not mean certified non-GMO. Many food products and nutritional products claim to be non-GMO but do not provide certification of that status. Any company that self-proclaims its products to be non-GMO has to back it up with certification. Gluten-free does not mean non-GMO. Gluten free products should be avoided unless it is certified non-GMO.

Since gluten free foods are often corn based, they are usually made with containing BT toxin, which is a deadly insecticide. Trans-Fat Free does not mean the food is free from trans fats. In fact, in the U.S. Alone, the FDA currently allows foods containing up to 0.5g of trans fats per serving to claim zero grams of trans fats per serving, which is completely misleading. Choosing one food item over another for reasons such as products claiming they are all natural or fat free do not always mean it’s healthier.

The FDA does not define “natural” but if labeled so, the food must not contain added colors, artificial flavors, or synthetic substances. However, foods labeled natural can contain preservatives. Companies will argue that natural products that contain high fructose corn syrup are healthy because it comes from corn. No sugar added items are often bought but also not fully understood. Foods like fruit, milk, cereals, and vegetables naturally contain sugar.

Although there may not have been added sugar, they still contain natural sugars. These sugar free products may contain added ingredients like maltodextrin, which is a carbohydrate. Carbohydrates may be simple sugars or complex starches that can raise blood sugar. Just because “no sugar added” is labeled does not mean the product is calorie free or carbohydrate free which most consumers often misunderstand. Most consumers are ignorant about the actual nutritional content of their foods and heavily rely on the food labels and claims that are provided on packages. This over-reliance on a variety of different claims has many implications including uninformed customer purchases and over-consumption of unhealthy foods.

FDA Guidelines [ ] The FDA has guidelines for what is considered a misleading label. There are rules for the size of the font and what to name food products. The name must include what the food actually is, that means if the food is canned carrots the can must have Carrots on the label.

If the food of the product doesn’t “exist” then the label must give the consumer some idea of what the food contains. The FDA states the name should be a “statement of identity” meaning the company can't make up a new name for an already existing food. Something must be called an imitation if its nutritional values are significantly different than the original food. With drinks/beverages that want to be called juice must have the percentage of the fruit or vegetable in the juice. The name of the juice must be from its more prominent fruit or vegetable by volume. For example Coca Cola tried to sell pomegranate juice, which only had.3% pomegranate in it so they had to change the label. (POM Wonderful) For a beverage/drink to be called juice it must be 100% juice, if it's less than 100% then it must be called a drink or beverage.

Marketing and Consumer Perceptions [ ] Many companies have started to use their packaging for food as a marketing tool. Words such as “healthy”, “low-fat”, and “natural” have contributed to what is called the, which is when consumers overestimate the healthfulness of an item based on claims on the packaging. Today, food companies incorporate whole grain and higher fiber levels into their products in order to advertise these advantages.

With that in mind, there is no regulated amount of grain needed in a certain product to be able to advertise this benefit, so it is important to note that companies advertising this may not be as healthy as they would like to appear. Other studies have shown that marketing for food products has demonstrated an effect on consumers’ perceptions of purchase intent and flavor of the products.

One study in particular performed by Food and Brand Lab researchers at Cornell University looked at how an Organic label affects consumers’ perceptions. The study concluded that the label claiming the product was “organic” altered perceptions in various ways.

Consumers perceived these foods to have fewer calories and stated they were willing to pay up to 23.4% more for the product. The taste was supposedly “lower in fat” for the organic products as opposed to the regular ones. Finally, the study concluded that people who do not regularly read nutrition labels and who do not regularly buy organic food products are the most susceptible to this example of the health-halo effect. Because of this it is now important for consumers to be aware of the ways in which food companies alter their nutrition labels. See also [ ] • • • • • • • (for calculating available food energy) • References [ ] Wikimedia Commons has media related to. Retrieved 2013-01-26.

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