What is CE Marking…? What is a Free Sales Certificate…? What is a EU Authorized Representative…? Entering the European market of medical devices and in vitro diagnostic medical devices is a challenge. Thousands of rules, regulations and legal terms around CE Marking make it even harder for manufacturers from countries outside of the EU to see clear. With our provident selected FAQs, we want to bring some light into this confusing topic.
List of FAQs regarding typical first issues of manufacturers in the Medical Devices and In Vitro Diagnostics industry
1. Why choose mdi Europa?
Because, we operate in an efficient, flexible and dedicated way. Worldwide. With tons of experience and excellent network partners.
Founded in 2000, we are still a family-owned business with a highly proficient and dedicated team, who registered hundreds of medical device manufacturers for CE Marking with the European competent authorities.
We exactly know the challenges and needs connected to small and medium-sized enterprises. Due to our lean structure, we not only safeguard flexibility and efficient pricing without hidden costs, but also continuing reliable guidance by one of our team members.
We provide a network of experts with excellent regulatory services around the world.
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2. What is CE Marking?
CE Marking commonly refers to the process of “obtaining” the CE Mark.
The CE Mark is an indication for the marketability of a product within the European Economic Area. There are certain Directives and Regulations, e.g. the legislation on medical devices and in vitro diagnostic medical devices that require manufacturers to CE Mark their devices. To learn more about CE Marking, please feel welcome to use the following links.
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3. What is a CE Certificate?
Certain types of products that fall under a CE Directive or Regulation must be reviewed by so-called Notified Bodies.
Notified Bodies have been designated by European competent authorities to verify that a manufacturer has completed the corresponding conformity assessment procedure. Upon verification, the Notified Body issues a CE certificate. See also the following link for more information on Notified Bodies.
To learn more about mdi Europa, you might use the following links
4. What is required to obtain a CE Mark?
Once a manufacturer has verified that a product falls under one of the CE Directives or Regulations, the company has to follow the corresponding conformity assessment procedure.
Typically, a medical device or in vitro diagnostic medical device manufacturer must fulfill the Essential Requirements or General Safety and Performance Requirements (SPR), conduct the belonging tests and inspections, compile the Technical File and finally draw up the Declaration of Conformity. Certain products must also be audited by a Notified Body. For further and more detailed information on what is required for medical device and in vitro medical device manufacturers, please use the following links.
To learn more about mdi Europa, you might use the following links
5. What are the tasks and responsibilities of a European Authorized Representative?
The exact role and responsibility of a European Authorized Representative, often also referred to as EU Authorized Representative, EU Auth. Rep., EC Rep or AR, is defined in the corresponding Directive or Regulation.
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), “‘Authorized Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations […]”. (Source: MDR, IVDR) As such, a European Authorized Representative will be responsible towards the EU competent authorities that you, the manufacturer, fulfill all duties and responsibilities as stipulated by the Regulations.
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6. Why do I need a European Authorized Representative?
Manufacturers of certain products, for example of medical devices or in vitro diagnostic medical devices, who have no location in Europe are obliged to engage a European Authorized Representative, often also referred to as EU Authorized Representative, EU Auth. Rep., EC Rep or AR.
This was a mandatory requirement as per the Medical Devices Directive 93/42/EEC (MDD), the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) and consequently also is a requirement as defined in Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
To learn more about mdi Europa, you might use the following links
7. What are the MDR and IVDR?
CE Marking of medical devices and in vitro diagnostic medical devices has been regulated under the Medical Devices Directive 93/42/EEC (MDD), the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) in the past.
May 26, 2021 and May 26, 2022 mark the date of full application of Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) becoming the legal framework for medical devices and in vitro diagnostic medical devices.
To learn more about mdi Europa, you might use the following links
8. What is a Declaration of Conformity?
The Declaration of Conformity is the manufacturer’s formal declaration that the devices listed on the document are in conformance with the corresponding Directive or Regulation.
It is a highly official and legally binding document that should only be signed by a senior officer. If you have any doubts how to set up your Declaration of Conformity, we are happy to help.
To learn more about mdi Europa, you might use the following links
9. What is a Technical File?
A Technical File often referred as Technical Documentation is required for all products falling under the medical devices legislation, including low risk class I medical devices, low risk in vitro diagnostic (IVD) medical devices and custom made devices.
The Technical Documentation is an essential element of the corresponding conformity assessment procedure.
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10. What is a conformity assessment procedure?
The conformity assessment of a product aims to demonstrate that all applicable requirements are met before it is placed on the market.
Conformity assessment procedures, also commonly referred to as conformity assessment routes, are pre-defined processes a manufacturer has to follow to declare conformity with a Directive or Regulation. mdi Europa has prepared an overview of the conformity assessment procedures under Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). To learn more about the conformity assessment procedure, please use the following links.
To learn more about mdi Europa, you might use the following links
11. What is a Free Sales Certificate?
A legalized Free Sales Certificate, also known as Certificate of Free Sales, Certificate of Marketability, FSC or CFS, acts as a proof of compliance with one of the most demanding regulatory systems in the world.
It is also often a fast and cost-efficient way to sell your products in markets outside the European Union. To learn more about Certificates of Free Sales, please use the following links.
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12. What are the costs involved for CE Marking?
The costs for obtaining the CE Mark are dependent upon many factors, e.g. the necessity to engage a Notified Body, outsourcing of internal processes to service providers.
Also, the fees for engaging an EU Auth. Rep. vary depending on the scope of services, type of products to be represented, etc. Please get in touch with mdi Europa to request a quotation and we will help to better estimate costs.
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13. What is a Notified Body (NB)?
A NB is a third-party organization that has been designated by a EU member state’s competent authority to carry out tasks related to conformity assessment procedures for the applicable legislation.
In our case, the applicable legislation refers to Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and to the Medical Devices Directive 93/42/EEC (MDD), the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD).
The involvement is not necessary for medical devices of class I unless they have a measuring function or are sold in sterile condition or (only applicable for the MDR) are reusable surgical instruments. For IVD products, a NB is only required when the product is listed under annex II of the IVDD. Under the IVDR all products need an NB unless the device falls into class A.
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Not found, what you were looking for? Please let us know: info@mdi-europa.com
