AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which defines an active implantable medical device as:

“any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure” additionally the directive requires that all active implantable medical device manufacturers must affix CE-Marking to the Directive in order to place their devices on the European Market. The AIMDD 90/385/ EEC also mentions the language requirement issue in Article 4.4, “when a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex I to be in their national language(s).”

Last updated Jun 25, 2009

Contact Us now to find out more.

Back to Obelis Directives

CPD 89/106/EEC (Construction Products Directive) was published on December 21, 1988 by the European Council on the approximation of laws, regulations and administrative provisions of the Member States. It was then amended by the Council Directive 93/68/EEC on July 22, 1993 and Regulation (EC) No 1882/2003 on September 29, 2003.  The directive harmonizes all construction products subject to regulatory controls for CE marking purposes.

The main goal of the Construction Products Directive is to improve the framework conditions for the competitiveness of the construction and construction products industries. The directive requires that construction products are suitable for use in construction works.  Therefore, the essential requirements regarding safety, public health, protection of citizens, and the environment must be fulfilled.

Last updated Mar 02, 2009

Contact Us now to find out more.

Back to Obelis Directives

PED 97/23/EC (Pressure Equipment Directive) adopted by the European Parliament and the European Council on May 29, 1997 was published on May 29, 2002. Previously, manufacturers of pressure equipment could decide if the product would meet the Pressure Equipment Directive requirements or continue applying the existing national legislation. On May 29, 2002, the PED was made obligatory throughout the European Economic Area.

The main aim of the Pressure Equipment Directive is to harmonize the European national legislations with regards to the design, manufacture, testing and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar gauge.  Pressure equipment can be represented by piping, vessels, safety accessories and pressure accessories. Assemblies means several pieces of pressure equipment assembled to form an integrated whole.

The directive arises from the “New Approach to Technical Harmonization and Standards” allowing for a flexible regulatory environment, without technical barriers to trade.

Last updated Mar 02, 2009

Contact Us now to find out more.

Back to Obelis Directives

The R&TTE Directive 1999/5/EC (Radio and Telecommunications Terminal Equipment Directive) was published on March 9, 1999. It covers all apparatuses using the radio frequency spectrum and all equipment associated with public telecommunications networks, for example mobile phones and wireless devices such as Bluetooth devices, wireless network routers and car door openers.

The directive ensures safety, protection and free movement of radio and telecommunications apparatuses in the European Economic Area. It also helps to increase access to third country markets and expand the opportunities of entering large trading blocs such as the USA and China, promote regulatory convergence between Member States and ensure that research and innovation will benefit the sector. The directive does not apply to radio equipment, kits of components to be assembled by radio amateurs, equipment covered by the 96/98/EC Directive on marine equipment, 93/65/EEC Directive on civil aviation, cabling and wiring, equipment designed to only receive sound, TV broadcasting services, and air traffic management systems.

EU Directives which may apply to radio and telecommunications equipment are the Low Voltage Directive 2006/95/EC and the Electromagnetic Compatibility Directive 2004/108/EC.

Last updated Mar 02, 2009

Contact Us now to find out more.

Back to Obelis Directives

CE Marking Directive 93/68/EEC of July 22, 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery),

89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

Last updated Oct 01, 2009

Contact Us now to find out more.

Back to Obelis Directives

TSD 88/378/EEC (Toy Safety Directive), Council Directive 88/378/EEC of March 3, 1988 was published on January 1, 1990 on the approximation of the laws of the Member States concerning the safety of toys.

The safety of toys is harmonized at the European level so that the essential requirements can be met at the manufacturing stage. The standards laid down by the European standardization bodies provide evidence of compliance with the essential requirements. Toys that meet these requirements bear the CE marking.

The Toy Safety Directive (TSD) 88/378/EEC came into force on January 1, 1990. Since then, toys placed in the European Economic Area must bear the CE marking.

A toy is defined as “any product or material designed or clearly intended for use in play by children
of less than 14 years of age”.

The primary requirement is that toys meet the essential safety requirements of the directive. Toys must either be manufactured in accordance with harmonized standards, or must be type tested by a notified body in order to demonstrate that they comply with the essential requirements
of the directive.

For products which are manufactured fully in accordance with the requirements of the harmonized standards, manufacturers may self-certify to the directive without involving a notified body. However, many large retailers will require an independent report as a condition of supply, even though this is not a legal requirement.

Additionally, the directive requires that the manufacturer should put the CE logo on the product and maintain a file containing certain items of information about the toys.

Second hand toys (i.e. those which were first sold within the European Community before January 1, 1990) do not have to be CE marked, but they must meet the essential safety requirements.

Last updated Jan 07, 2010

Contact Us now to find out more.

Back to Obelis Directives

MSD 98/37/EC (Machinery Safety Directive) of the European Parliament and of the Council of June 22, 1998 was published on January 1, 1993. It has been amended according to the 2006/42/EC. The directive is in approximation of the laws of the Member States relating to machinery. It provides the harmonization of the essential health and safety requirements for machinery in the European Economic Area.

The Machinery Directive came into force on January 1, 1993 and has been mandatory since January 1, 1995. From that date, no machine can be placed in the European Economic Area or installed if it does not bear the CE marking.

According to the directive, machinery is “an assembly of linked parts or components,
at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging
of a material”. The manufacturer is responsible for verifying whether a particular product falls within
the scope of the Machinery Directive.

The directive both promotes the free movement of machinery within the market, and guarantees a high level of protection to EU workers and citizens.

Current Problems with Directive 98/37/EC

• Overlap between the Machinery Directive and the Low Voltage Directive
• Consideration as to how the provisions of EMC should be applied to machinery within the scope of this directive
• Lack of transposed harmonized standards to support the directive
• The scope of the directive is not entirely clear and, therefore, the definition of “machinery” needs to be refined

Last updated May 07, 2009

Contact Us now to find out more.

Back to Obelis Directives

EMC Directive 2004/108/EC (Electromagnetic Compatibility Directive) of the European Parliament and of the Council was published on December 31, 2004 in the Official Journal of the European Union, L 390/24, and replaced Directive 89/336/EEC on July 20, 2007.

2004/108/EC Directive regulates the electromagnetic compatibility (EMC) of both apparatus and fixed installations.

The directive applies to most electrical and electronic apparatuses, that is, finished products and systems that include electrical and electronic equipment.

• The main objective of the EMC Directive is thus to regulate the compatibility of equipment regarding EMC. In order to achieve this objective, provisions have been put in place so that: equipment (apparatus and fixed installations) need to comply with the requirements of the EMC Directive when it is placed on the market and/or taken into service.
• The application of good engineering practice is required for fixed installations, with the possibility for the competent authorities of Member States to impose measures if non-compliance is established.

Last updated May 11, 2009

Contact Us now to find out more.

Back to Obelis Directives

LVD 2006/95/EC ( Low Voltage Directive) of the European Parliament and of the Council of December 12, 2006 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version) was published in the OJEU L 374 on December 27, 2006, p. 10-19. It entered into force on the 20th day following that of its publication, i.e. on January 16, 2007. The old directive 73/23/EEC was repealed on the same date.

The Low Voltage Directive (LVD) 2006/95/EC ensures that electrical equipment provides a high level of protection for European citizens in the European Union.

The Low Voltage Directive 2006/95/EC requires electrical equipment to have protection against hazards that could arise from within the electrical equipment itself or from external influences. The directive covers all risks arising from the use of electrical equipment, including mechanical, chemical (such as, in particular, emission of aggressive substances) and all other risks. The directive also covers noise and vibration, and ergonomic aspects which could cause hazards within the scope of the directive.

The term “electrical equipment” is not defined in the directive. It is to be interpreted according to the internationally recognized meaning of this term. The definition of electric equipment in the International Electro Technical Vocabulary of IEC (International Electro Technical Commission) is: “item used for such purposes as generation, conversion, transmission, distribution or utilization of electrical energy, such as machines, transformers, switchgear and control gear, measuring instruments, protective devices, wiring material, current-using equipment.” “Domestic” plugs and sockets may also be used in commercial or industrial premises for uses which do not require specialized industrial features.

The general requirements of the directive are:

• The equipment satisfies the essential health and safety requirements of the directive
• The appropriate conformity assessment procedure has been carried out, supported by drawing up a Technical Construction File
• An EC Declaration of Conformity has been issued by the responsible person
• CE marking has been affixed, showing that the manufacturer has complied with these essential safety requirements
• The electrical equipment is safe

Last updated May 07, 2009

Contact Us now to find out more.

Back to Obelis Directives

PPE Directive 89/686/EEC (Personal Protective Equipment Directive) was published on June 1995 and covers Personal Protective Equipment (PPE). It is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”.

89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and 6 Annexes. Originally published in 1989, the PPE directive only has three modifications 93/95/EEC, 93/68/EEC, and 96/58/EEC.

The introduction establishes the focus of the directive as “safeguarding of public health, improving safety at work and ensuring user protection” and reinforces the European Commissions continuing efforts to create free movement of goods in the European Economic Area through the use
of harmonized standards.

The directive divides PPE into 3 categories; class 1 - simple, class 3 - complex and class 2 - neither of these. For classes 1 and 3 there are comprehensive lists of equipments covered; any equipment not included on either list are classed in the second category. There is also a comprehensive list of equipment excluded from the directive. There are general requirements for all 3 classes, including technical documentation, a CE mark and a Declaration of Conformity. For classes 2 and 3 there are additional requirements.

Current Problems

Awareness and communication continue to be major problems across the EU for the smooth implementation of the directive. Some of the problems identified are:

• Scope: unclear about applicability to consumer PPE for domestic use; also demarcation between PPE and other directives, e.g. Medical Devices and Toys require clarification.
• Standards: still not available for all PPE
• Product Categorization/Conformity
• Assessment Procedures: require clarification to allow an increased scope for self-certification in order to ease demands on third-party testing and reduce compliance costs
• Notified Bodies: greater transparency and uniformity is required across member states in the assessment of applicants for Notified Body status in order to increase confidence in their appointment and activities

Last updated Mar 02, 2009

Contact Us now to find out more.

Back to Obelis Directives

The Cosmetics Directive 76/768/EEC was published on July 27, 1976. It allows cosmetic products in the European Economic Area to circulate freely and ensures their safety for use. A cosmetic product is any substance intended to make contact with external parts of the human body, or inside the mouth, with the intention of cleaning or perfuming them, changing their appearance, correcting odors, protecting them or maintaining their good condition. These products must not be harmful to health when used under normal conditions.

The Cosmetics Directive sets out certain standards cosmetic products must meet before they can be placed in the European Economic Area, such as substances that cannot be included in the formula of the products, requirements for labeling and packaging, rules for market surveillance and notification to the competent authority of each member state and laws relating to animal testing. Since it was introduced, the Cosmetics Directive has been amended by the European Parliament and the European Council 55 times in order to keep up with the changing market for cosmetics.

Other EU directives and regulations which may apply to cosmetic products are the 94/62/EC Packaging and Labelling Directive, the (EC) REACH 1907/2006 Directive, permitted and restricted ingredients, cosmetic guidance documents and European Court of Justice rulings. The Cosmetics Directive is applicable in all of the 27 EU Member States, as well as EFTA/EEA countries.

The Cosmetics Directive 76/768/EEC is outlined below:

Ingredients – Under Annex II, certain substances are listed that cannot be used in the composition of a cosmetic product, and Annex III states a list of substances that cosmetic products can only contain under certain restrictions.
Labelling – Packaging and containers must show:

• The name and address or registered office of the manufacturer or person responsible for the marketing of the cosmetic product
• The weight or volume of the product at the time of packaging
• A ‘’Best used before’’ date for products with a durability of less than 30 months, and for products with a durability of more than 30 months the period of time for which the product can be used without causing harm to the consumer after the product has been opened.
• Precautions for use
• An identification number
• The function of the product
• A list of ingredients in descending order

This information must be in the official language or languages of the EU Member State.

Market surveillance – Product safety information must be kept available to the monitoring competent authorities. Member States must also ensure that the products comply with the directive, and that cosmetic products do not claim to have characteristics that they do not actually hold.

Notification to Competent Authority – The manufacturer, or whoever is responsible for placing the cosmetic product on the EU market, must notify the authority of the Member State of the place where the product is manufactured, or the place where it was first imported into the EU, before the product can be placed in the EEA.

Animal Testing – The Directive puts a ban on testing finished cosmetic products on animals, and bans marketing products that have been tested on animals. The ban on testing ingredients of cosmetic products on animals will apply progressively, as will the ban on marketing of these ingredients.

Last updated May 06, 2009

Contact Us now to find out more.

Back to Obelis Directives

The GPSD 2001/95/EC (General Product Safety Directive) was published on January 15, 2004. In order to place products in the European Economic Area, distributors and manufacturers must comply with this directive. The aims of the directive are to protect consumers’ health and safety and to ensure the EEA functions properly in relation to this directive.

The GPSD 2001/95/EC is designed to protect consumers from unsafe products. These harmonized standards and essential requirements must be met for products to be placed in the European Economic Area. Some examples of products that fall under this directive include sports equipment and household products. Specifically, any product that will be used by consumers or may be used by them unintentionally must comply with this directive.

A “safe” product is defined in this directive as any product, when used under normal circumstances, that does not contain any risk to the users or the risks are minimized that is compatible with the product’s use. The product will undergo a safety assessment, and only when the product is deemed ‘’safe’’ will it be allowed to be placed in the EEA. Along with this, producers must provide the necessary information on the product warning the user of the risks associated with the product. This must include:

• Relevant information to enable consumers to assess the risks inherent in the product throughout the normal or reasonably foreseeable period of its use
• Information to consumers of risks which the product might pose
• Choose to take appropriate action including, if necessary to avoid these risks, withdrawal from the market, adequately and effectively warning consumers or recall from consumers

Under certain conditions, if a product is deemed to be unsafe, the European Commission can ban the marketing of it, recall it from customers and withdraw it from the market. 

The Member States of the EU must enforce the requirements of the GPSD on manufacturers and distributors of products. They must also appoint authorities to be in charge of market surveillance.

The directive provides an alert system, the RAPEX system, which ensures the exchange of information about risk assessments, dangerous products and scientific development amongst other aspects necessary for control of safety of products. It also helps to promote joint testing and surveillance projects, the exchange of expertise and cooperation within the EU.

Last updated May 07, 2009

Contact Us now to find out more.

Back to Obelis Directives

IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own separate set of requirements for manufacturers wishing to place medical devices in the European Economic Area. This directive does not specifically list out the devices that fall under it. Rather, the responsibility is placed on the manufacturer to determine what directives apply to their device. The directive sets out device requirements, requirements for manufactures placing the device on the market, and also demands on safety and quality of the devices.

Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as “any medical device which is a reagent, reagent device, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.

Last updated May 06, 2009

Contact Us now to find out more.

Back to Obelis Directives

MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007. The consolidated directive will become mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article. This includes if this device is used alone or in combination with software necessary for its proper application intended by the manufacturer to be used for human beings in the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• investigation, replacement or modification of the anatomy or of a physiological process control of conception and which does achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means.

The Medical Device Directive calls for all manufacturers who distribute in the European Economic Area to comply with essential requirements that benefit the safety of those in the EEA. The devices must be designed and manufactured in such a way that as they are used by patients, they will in no way compromise the health of the patient. Other areas included and outlined in the directive are requirements regarding design and construction, materials used in the production of the device, and reduction of risk as far as possible to the patient.  The directive ensures that the performance of the device promised by the manufacturer is achieved. The Medical Device Directive is necessary due to the differences of safety, health protection, and performance characteristics among Member States and thus causes barriers to trade within the Community.  The harmonized standards of the Medical Device Directive allow for free movement within the market.

The MDD 93/42/EEC has recently been amended. The 2007/47/EC amendment was established on September 5, 2007 and the consolidated directive will be mandatory on March 21, 2010. The amendment is necessary due to continual advancements in technology and development of international initiatives.  The Commission is to constantly analyze the directives in order to ensure the protection of the patients.  The amendment has such changes as the definition of a medical device, things which are not considered a medical device, explanation of Member State’s role, etc.

Last updated Mar 02, 2010

Contact Us now to find out more.

Back to Obelis Directives