EUROPEAN REGULATORY COMPLIANCE SERVICES

EUROPEAN AUTHORISED REPRESENTATIVE SERVICES (E.A.R.)
REGISTRATION and NOTIFICATION SERVICES
EUROPEAN REGULATORY COMPLIANCE SERVICES
CONSULTING SERVICES IN THE FIELD OF EUROPEAN CERTIFICATION

Non-EU based manufacturers are legally obliged to appoint European Authorized Representatives (E.A.R) and Person Responsible for Regulatory Compliance (PRRC) or Person Responsible for Compliance Information (PRCI) in order for their products to legally circulate within the EU Market.

2017/745 REGULATION
medical devices (mdr)

is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.

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2017/746 REGULATION
in vitro diagnostic (IVDR)

is a regulation of the European Union on the placing on the market and putting into service of

in vitro diagnostic

medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.

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1223/2009 REGULATION
cosmetic products

establishes the basis for the regulation that cosmetic products must comply with in order to be marketed in Europe. Among the obligations that companies that market cosmetic products must comply with are those of having a qualified Responsible Person established within the Union to ensure compliance with regulations and product safety for public health.

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1907/2006 Regulation
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.

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2014/68/EU Directive
PRESSURE EQUIPMENT (PED)

Directive sets out the standards for the design and fabrication of pressure equipment generally over one litre in volume and having a maximum pressure more than 0.5 bar gauge..

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2009/48/EC DIRECTIVE
safety of toys (TSD)

The European Parliament and Council Directive 2009/48/EC on the safety of toys (“TSD” – Toy Safety Directive) was published on 30 June 2009 and entered into force on 20 July 2009 aimed to entirely repeal the TSD 88/378/EEC (Toy Safety Directive), Council Directive 88/378/EEC of March 3, 1988 which was published on January 1, 1990.

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2021/1433 regulation
Personal protective equipment (PPE)

Personal protective equipment (PPE) is defined as ‘any device to be worn or held by an individual for protection against one or more health and safety hazards’. The PPE Directive 89/686/EEC was repealed with effect from April 2018 and the PPE Regulation (EU) 2016/425 now applies.

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2019/1020 REGULATION
CE products

On July 16, 2021, Regulation (EU) 2019/1020 of the European Parliament and of the Council of June 20, 2019 on market surveillance and compliance of products fully comes into force. It will form the core of European market surveillance law and is intended to provide a uniform and efficient implementation and enforcement of product regulatory requirements.

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Authorized Representatives E.A.R. FOR MEDICAL DEVICES MANUFACTURES

Authorized Representatives shall be qualified/professional and possess the necessary expertise of the regulatory requirements for medical devices in the EU for the 2017/745 Medical Device Regulation compliance.

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Representative For CE marking

The producer can be based anywhere in the world, and he needs to appoint an Authorized Representative in the EU. He should be authorized by the manufacturer to perform certain tasks required in the applicable Directives. The CE marking Directive states that the appointed Representative in the EU should work on behalf of the producer.

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PRRC for MD Manufacturers

PRRC stands for person responsible for regulatory compliance. It is one of the newly introduced requirements of the European Union's Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR).
It intends to ensure companies have a qualified regulatory expert at their disposal.

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PRRC for E.A.R

The PRRC for an authorized representative and for a manufacturer based outside EU cannot be same. In the regulations for authorized representative, it is clearly mentioned that PRRC will be an additional level of scrutiny. Therefore, if the same person acts as PRRC for both, the additional level of scrutiny would be compromised.

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Fulfilment Service Provider for CE marking products

Since July 16, 2021, a new EU regulation on product safety (the “Market Surveillance Regulation (EU) 2019/1020”) has been in effect. This new regulation requires CE-marked products to have someone present in the European Union acting as the point of contact for product compliance (a “ Fulfilment Service Provider ”).

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EUDAMED

EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers).

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CPNP portal

The cosmetic products' notification portal (CPNP) is a free of charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

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national registration

The harmonization of medical devices under EU MDR means that medical devices are now subject to one single set of regulatory requirements. This means that a medical device type-examined in one Member State can be placed on the market anywhere within the EU.

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CFS or FSC

As the EU legislative requirements are well-revered worldwide, after a product has successfully gained EU Compliance, other global markets may request a Certificate of Free Sale (CFS) or Free Sale Certificate (FSC). Often referred to as a Free Trade Certificate, Certificate of Free Sales, etc; this certificate can be obtained from the EU Competent Authorities for fully compliant products in order to streamline market entry into their own global markets.

frequently asked questions

Frequently asked questions about the role of the European Authorized Representative for Non-EU manufacturers of medical devices

FAQ

glossary

The list of terms in a European Regulatory Compliance with the definitions for terms.

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our news

Notes on the problems of European legislation and events in this field.

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Consulting agency "AFINA"
PRAGUE, CZECH REPUBLIC.

Our company is located in the heart of modern Europe, the city of Prague. The

firm was founded in 1996. Therefore, we managed to gain experience that will allow us to avoid many mistakes on the way of business.
Our employees speak many languages, and it is easier for us to resolve issues directly, bypassing intermediaries. This saves you time and money. Our competence and knowledge of European legislation will allow you to accurately choose the right strategy for entering the EU market in terms of the law.
We are a registered Authorized Representative with the number CZ-AR-00000058 in EUDAMED. We also have full legally recognized competencies to provide PRRC services in the field of medical devices within the EU.

Kaprova 42/14

Prague 110 00

+420 608 049 029

Czechia

We offer

EUROPEAN AUTHORISED REPRESENTATIVE SERVICES (E.A.R.)
REGISTRATION and NOTIFICATION SERVICES
EUROPEAN REGULATORY COMPLIANCE SERVICES
CONSULTING SERVICES IN THE FIELD OF EUROPEAN CERTIFICATION