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  Services for export in the EU

 

COMPODYNAMIC offers, since 1994, an advanced and complete range of services for the foreign companies that want to export products and services in the European market.

COMPODYNAMIC helps and supports its customers to manage all the obligations the European law and regulations provide for marking of conformity, appointment of Authorised Representative, meet the European and international standards and fulfill the requests of national and European authorities.

 COMPODYNAMIC also assists its customers for custom compliance, risks analysis/assessment/management, technical support, translation, accreditation and representation before the European bodies, classification, labelling and packaging.

EU Authorised Representative

 

According to the EU laws, a manufacturer that is not established within the European Union must  appoint a representative, a person other than the importer or the distributor, who will represent the manufacturer in the whole European Union (whereas may have many distributors and/or sales agents in the EU). The duties of the EU Authorised Representative are firstly those of being a point of contact for the European and national authorities responsible for market surveillance and product safety, that may contact at any time the Authorized Representative for information about the products. 

Manufacturers are obliged in ensuring that their products, placed on the extended Single Market of the EEA (28 European Union Member States + Iceland, Liechtenstein and Norway) meet European safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the European market. 

A non-EU manufacturer, to affix the CE marking on the product have to identify, firstly, the applicable directive and harmonised standards, verify the product specific requirements and identify if an independent conformity assessment is necessary; after having tested the product and checked its conformity, draw up and keep available the required technical documentation together with the EU Declaration of Conformity. 

The EU regulations set a list of products for which, due to the higher safety risks, safety cannot be checked by the manufacturer alone and must be performed by an independent organisation, a notified body appointed by national authorities. 

Under the EU decision N. 768/2008/EC on a common framework for the marketing of products, the Authorized Representative shall perform the tasks specified in the mandate received from the manufacturer. The “new approach” directives have an explicit obligation of the written form for the appointment of the Authorized Representative by the manufacturer. 

EU Authorised Representative service

COMPODYNAMIC provides a full service for the appointment of the EU Authorised Representative for the following product groups:

MEDICAL DEVICES (IVD, AIMDD) – LOW VOLTAGE APPLIANCES – PERSONAL PROTECTIVE EQUIPMENT – CONSTRUCTION PRODUCTS – MACHINERY – TOYS – SMALL AND MEDIUM BOATS – RADIO AND TELECOMMUNICATION EQUIPMENT –   BOILERS –  PRESSURE EQUIPMENT – PYROTECHNICS – ENERGY RELATED PRODUCTS

 

As EU Authorised Representative COMPODYNAMIC carries out the following tasks:

  • - Notification to competent authorities of Products, their performance, characteristics and changes (registration, renewal, update)
  • - Keep the EU declaration of conformity and the technical documentation
  • - Provide, upon request of the authority, all the information and documentation, to demonstrate the conformity
  • - Reporting of incidents, authorities' actions, products recall, corrective actions
  • - Cooperate with the national competent authorities, at their request, on any action taken to eliminate the risks

 

COMPODYNAMIC also offer other services:

Technical consulting

  • Technical Advice, standards testing and compliance, conformity evaluation, labelling and packaging, translations. 

Legal advisory

  • European legislation advice (EU decision 768/2008/CE and related), regulatory guidance, national regulation understanding.

Business support

  • Importers, sales and trade representatives research, marketing services, internet and social media services.

 

 

 For  the list prices for the categories of products, please contact us, we will send the specific rates. Our price policy is to offer the best price and to provide additional discount for more orders.

 

 EU Authorized Representative Service for Medical Devices  

 

 EU Authorized Representative Service for Personal Protective Equipment  

 

 EU Authorized Representative Service for Toys 

 

FEEL FREE TO CONTACT US ! 

 

COMPODYNAMIC offers the EU Authorised Representative service also for the MEDICAL DEVICES manufacturers, located outside the European Economic Area.

After a long period of revision, that had involved all the European institution and stakeholders for five years, the final texts of the new regulations, that will update the existing EU rules, is expected to enter in force before June 2017.

The current EU regulatory framework for medical devices consists of European Directive 90/385/EEC on active implantable medical devices (AIMDD) and Directive 93/42/EEC on medical devices (MDD) which cover a huge spectrum of products. Separate rules regard the in vitro diagnostic medical devices (IVDs), such as blood tests, which are covered by Directive 98/79/EC.

The MDD divides them into four classes of risk:

class I (low risk, e.g. sticking plasters, corrective glasses),

class IIa (medium-low risk, e.g. tracheal tubes, dental filling material),

class IIb (medium-high risk, e.g. X-ray machines, bone plates and screws) and

class III (high risk, e.g. heart valves, total hip replacements, breast implants).

Active implantable medical devices (e.g. pacemakers, implantable defibrillators) covered by the AIMDD fall into class III.

Medical devices are not subject to any pre-market authorisation by a regulatory authority but to a conformity assessment which, for medium and high risk devices, involves an independent third party, known as ‘notified body’. The Notified body is designated and monitored by a Member State and acts under the control of the national authorities. Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey.

In an internal market with 32 participating countries and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, on the safety of medical devices and their free movement within the internal market. This upcoming revision aims to overcome these flaws and gaps and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices, to the benefit of patients and healthcare professionals.

The new Regulation’s scope is extended to some products currently not covered by the AIMDD/MDD. And on the other hand, some products which, in some Member States, are placed on the market as medical devices are excluded from its scope.

The extension of the scope concerns:

Products manufactured utilising non-viable human tissues or cells, or their derivatives, that have undergone substantial manipulation (e.g. syringes prefilled with human collagen), unless they are covered by Regulation (EC) No 1394/2007 on advanced therapy medicinal products.

Certain implantable or other invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile (e.g. non-corrective contact lenses, implants for aesthetic purposes).

Additional provisions have been included. They concern:

Products that contain or consist of viable biological substances (e.g. living micro-organisms);

Food covered by Regulation on general principles and requirements of food law (e.g. this may affect certain slimming products).

The definitions section has been extended, aligning the definitions in the field of medical devices with international practice, such as the New Legislative Framework for the Marketing of Products and guidance documents produced by the Global Harmonization Task Force (GHTF) for medical devices.

A new chapter redefines the obligations of economic operators, reprocessing, CE marking, free movement.

The regulatory instrument of ‘common technical specification’ (CTS), which has proven useful in the context of the IVDD, has been introduced in the broader field of medical devices to further specify the general safety and performance requirements and the requirements on clinical evaluation and post-market clinical follow-up. Such requirements however, leave manufacturers the possibility of adopting other solutions that ensure at least an equivalent level of safety and performance.

The new legal obligations on manufacturers are proportionate to the risk class of the devices they produce. For example, this means that even though all manufacturers should have a quality management system (QMS) in place to ensure that their products consistently meet the regulatory requirements, the QMS-related responsibilities are stricter for manufacturers of high risk devices than for manufacturers of low risk devices. Manufacturers of medical devices for an individual patient, so called ‘custom-made devices’, must ensure that their devices are safe and perform as intended, but their regulatory burden remains low.

Key documents for the manufacturer to demonstrate compliance with the legal requirements remain the technical documentation and the EU declaration of conformity, to be drawn up in respect of devices placed on the market.

In this field new concepts have been introduced:

The requirement of a 'qualified person' within the manufacturer’s organisation, that should be responsible for regulatory compliance.

Clear conditions for enterprises involved in relabelling and/or repackaging medical devices, for the case of 'parallel trade' and to assure free movement of goods.

New stricter rules for the reprocessing of single-use devices.

New obligations regard identification, traceability and registration of devices and economic operators

The economic operators must be able to identify who supplied them and to whom they have supplied medical devices, the manufacturers must fit their devices with a Unique Device Identification (UDI) which allows traceability. The UDI system will be implemented gradually and proportionate to the risk class of the devices.

The manufacturers, their Authorised Representatives and importers must register themselves and the devices they place on the EU market in a central European database: the European databank on medical devices (Eudamed), set up by Commission Decision 2010/227/EU, which will contain integrated electronic systems on a European UDI, on registration of devices, relevant economic operators and certificates issued by notified bodies, on clinical investigations, on vigilance and on market surveillance.

The new Regulation replaces and repeals Council Directives 90/385/EEC and 93/42/EEC, it will become applicable three years after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. The European Commission needs time to put in place the IT infrastructure and the organisational arrangements necessary for the functioning of the new regulatory system.

 

WHAT EXACTLY WILL CHANGE? 

• Wider, clearer scope for EU legislation on medical devices – extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests

• Stronger supervision of independent assessment bodies by national authorities

• More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections

• Clearer rights & responsibilities for manufacturers, importers and distributors, which would also apply to diagnostic services and internet sales

• Extended Eudamed database on medical devices – will provide comprehensive information on products available on the EU market. Non-confidential data will be publicly available

• Better traceability of medical devices throughout the supply chain – enabling a swift and effective response to safety problems (e.g. recalls)

• Stricter requirements for clinical evidence to support assessments of medical devices

• Updated classification rules dividing medical devices into 4 different risk categories and health & safety requirements, including labelling rules – to keep pace with technological and scientific progress

• Better coordination between national surveillance authorities, with the Commission providing scientific, technical and logistic support

• International guidelines to be incorporated into EU law.

COMPODYNAMIC