Aesthetic Devices

Products which are aimed to improve or change a person’s appearance (cosmetic lasers, colored contact lenses, etc) for aesthetic purposes alone are most commonly regulated under Electromagnetic Compatibility Directive and/or the Low Voltage Directive.

With the impending Medical Device Regulation, we will find that many of these aesthetic devices will come to be classified under this legislative framework. This will require implementation and certification under the ISO 13485 and, in most cases, engaging a Notified Body to issue a CE Certificate.

Electromagnetic Compatibility Directive

Any product placed and made available on the EU Market (either through e-commerce or brick-and-mortar) must comply with the Electromagnetic Compatibility Directive 2014/30/EU.

Non-EU manufacturers wishing to make their products available to EU citizens should appoint an Authorized Representative. (A manufacturer is defined as any natural or legal person who manufactures apparatus or has apparatus designed or manufactured, and markets that apparatus under his name or trademark.)

Products which fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines or total destruction of the products.

The EMC Directive 2014/30/EU (Electromagnetic Compatibility Directive) of the European Parliament and of the Council was published on March 29, 2014 in the Official Journal of the European Union, L 96/79, and replaced Directive 2004/108/EC on the 18th April 2014.

The EMC Directive 2014/30/EU regulates the electromagnetic compatibility of equipment –  apparatus and fixed installations.

In order to achieve this objective, equipment need to comply with the essential requirements of the EMC Directive when it is placed on the market and/or put into service. The requirements limit electromagnetic emissions to a level that will not affect radio and telecommunications or other equipment and require products to have immunity to electromagnetic disturbances.

The EMC Directive does not regulate the safety of equipment in respect of people, domestic animals or property, therefore, it is not a safety related Directive.

Functional safety aspects based on electromagnetic disturbances are regulated for instance by the Machinery Directive 2006/42/EC, the Low Voltage Directive 2014/35/EU and the General Product Safety Directive 2001/95/EC.

  • Chapter 1: General provision – Article 1-6
  • Chapter 2: Obligation of economic operators – Article 1-12
  • Chapter 3: Conformity of equipment – Article 13-19
  • Chapter 4: Notification of conformity assessment bodies – Article 20- 36
  • Chapter 5: Union market surveillance and control of apparatus entering the Union market ad Union safeguard procedure – Article 37-40
  • Chapter 6: Committee, Transitional ad final provisions – Article 41- 47
  • Annex I: Essential requirements
  • Annex II: Module A: Internal production control
  • Annex III: Part A – Module B: EU-type examination; Part B – Module C: conformity to type based on internal production control
  • Annex IV: EU declaration of conformity
  • Annex V: Time-limit for transposition into national law and date of application
  • Annex VI: Correlation table

Electric devices and installations are a core component of our lives on a nearly moment to moment basis. The main considerations of the electromagnetic compatibility legislations is to ensure the safety when in use both alone and in close proximity to other electronics.

Until the publication of the Electromagnetic Compatibility Directive 2014/30/EU on February 26, 2014 and the subsequent 2 year transition period, the Electromagnetic Compatibility Directive 2004/108/EC was the reigning legal framework for EMC products.

From April 20, 2016 the Electromagnetic Compatibility Directive 2014/30/EU became fully applicable in the EU as the main legal framework for EMC products.

The EMC Directive 2014/30/EU applies to a vast range of equipment encompassing electrical and electronic appliances, systems and installations. This Directive covers products which are new to the Union market when they are placed on the market, as well and it applies to all forms of supply, including distance selling, as well.

  • Electrical and electronic appliances, systems, and installations including electrical and electronic appliances;
  • Fixed installations;
  • Devices and sub assemblies intended to be included in an apparatus by the end user and mobile installations.

This directive shall not apply to:

  • Equipment covered by the Radio and telecommunication terminal directive (R&TTE) and Radio Equipment Directive (RED);
  • Radio equipment used by radio amateurs;
  • Equipment where EMC is covered by other specific directives, such as marine equipment if covered by Directive 96/98/EC or active implantable medical devices under the 90/385/EEC Directive;
  • Aeronautical products;
  • Equipment incapable of generating or contributing to electromagnetic emissions and/or operates without unacceptable degradation in the presence of electromagnetic disturbance as normally seen in its intended use;

Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

There are two potential paths  for the Conformity Assessment Procedure that a manufacturer may elect to follow before making their products available on the EU Market.

  1. Internal Production Control (Annex II), or
  2. Conformity to type based on internal production control + EU-type Examination (Annex III)

Technical Documentation
It must be prepared by the manufacturer and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall be drafted up according to the conformity assessment procedure followed by the manufacturer.

Essential requirements for all equipment
Equipment shall be so designed and manufactured as to ensure that:

  • The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
  • It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.

Specific requirements for fixed installations
Fixed installations shall be installed applying good engineering practices and respecting the information on the intended use of its components.

It is the responsibility of the manufacturer to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves. Post-Marketing surveillance activities include, but are not limited to:

  • Staying up-to-date on new requirements or legislative changes,
  • Continual updating of the technical file as modifications are made to the product,
  • Reporting of any incidents related to the product use,
  • Removal of non-compliant batches from EU economics operators and end-user,
  • Keeping technical file available for 10 years after the last batch entered the EU market.

Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.

Non-compliant products enter the EU Market everyday – whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.

Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market. In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:

  • Being publicly reported to the RAPEX,
  • Warehousing Fees,
  • Requested Withdrawal,
  • Mandated Withdrawal,
  • Product Recall (from end-users and/or the market),
  • Complete ban on marketing of the product,
  • Destruction of the product,
  • Fines,
  • Revocation of the CE Marking.

The professionalism and expertise of the appointed Authorised Representative in dealing with various Competent Authorities and handling post-market surveillance case play a vital role in the successful recovery of your brand in the EU Market.

Low-Voltage Directive

Any product placed and made available on the EU Market (either through e-commerce or brick-and-mortar) must comply with the Low Voltage Directive.

Non-EU manufacturers wishing to make their products available to EU citizens should appoint a professional European Authorized Representative. (A manufacturer is defined as any natural or legal person who manufactures electrical equipment or has electrical equipment designed or manufactured, and markets that equipment under his name or trademark).

Intervention of a Notified Body is not required for any conformity assessment procedures described in this Directive.

Products which fail to comply may be subject to public notification (RAPEX), withdrawal/recall requirements, warehousing fees, fines or total destruction of the products and/or revocation of the CE Marking.

The LVD 2014/35/EU (Low Voltage Directive) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits is entered into force on the 20th April 2016 replacing the previous Directive 2006/95/EC. The Low Voltage Directive was one of the eight directives harmonised with NLF as a part of a so-called ’Alignment Package’.

The Low Voltage Directive ensures that electrical equipment provides a high level of protection of health and safety of persons, and of domestic animals and property.

Therefore, the Low Voltage Directive lays down the essential requirements to protect against hazards that could arise from within the electrical equipment itself or from external influences.

    • Chapter 1: General Provisions- Article 1-5,
    • Chapter 2: Obligation of economic operators- Article 6-11,
    • Chapter 3: Conformity of the electrical equipment – Article 12- 17,
    • Chapter 4: Union market surveillance and control of apparatus entering the Union market and Union safeguard procedure – Article 18-22,
    • Chapter 5: Committee, Transitional and final provisions – Article 23- 29,
    • Annex I: Principal elements of the safety objectives for electrical equipment designed for use within certain voltage limits,
    • Annex II: Equipment and phenomena outside the scope of this Directive,
    • Annex III: Module A – Internal production control,
    • Annex IV: EU Declaration of Conformity,
    • Annex V: Time-limits for transposition into national law and dates of application of the Directives set out in Part B of Annex V to Directive 2006/95/EC,
    • Annex VI: Correlation table.

The LVD Directive includes both electrical equipment and components designed for use with:

  • a voltage rating between 50 and 1000 V for alternating current (AC) or,
  • between 75 and 1500 V for direct current (DC).

These voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment. Any product with a voltage below 50 V will regulated under the General Product Safety Directive and Electromagnetic Compatibility 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.”

The LVD Directive includes both electrical equipment and components designed for use with a voltage rating between 50 and 1000 V for alternating current (AC) or between 75 and 1500 V for direct current (DC). These voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment.

Equipment listed in Annex II LVD 2014/35/EU are excluded from the scope of the Directive:

  • Electrical equipment for use in an explosive atmosphere,
  • Electrical equipment for radiology and medical purposes,
  • Electrical parts for goods and passenger lifts,
  • Electricity meters,
  • Plugs and socket outlets for domestic use,
  • Electric fence controllers,
  • Radio-electrical interference,
  • Specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate,
  • Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

In the main, these are items which are covered under other more specific directives or which are subject to international legislation outside of the jurisdiction of the EU.

Technical Documentation
The manufacturer puts together the technical documentation which makes it possible to assess whether the electrical equipment complies with the requirements of the directive. It contains at least the elements set out in the Annex III.

The essential requirements
The essential requirements cover all risks arising from the use of electrical equipment, including not just electrical ones but also mechanical, chemical (such as, in particular, emission of aggressive substances), health aspects of noise and vibration, and ergonomic aspects which could cause hazard within the scope of the LVD Directive.

It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves. Post-Marketing surveillance activities include, but are not limited to:

  • Staying up-to-date on new requirements or legislative changes,
  • Continual updating of the technical file as modifications are made to the product,
  • Reporting of any incidents related to the product use,
  • Removal of non-compliant batches from EU economics operators and end-user,
  • Keeping technical file available for 10 years after the last batch entered the EU market.

Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.

Evidently, non-compliant products enter the EU Market everyday – whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.

As there is no “approval” in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.

Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.

The main consequences include, but are not limited to:

  • Being publicly reported to the RAPEX,
  • Warehousing Fees,
  • Requested Withdrawal,
  • Mandated Withdrawal,
  • Product Recall (from end-users and/or the market),
  • Complete ban on marketing of the product,
  • Destruction of the product,
  • Fines,
  • Revocation of the CE Marking.

Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorised Representative.

Above all else, the professionalism and expertise of the appointed Authorised Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.

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