If your company manufactures Medical Devices and/or in-vitro diagnostics in a non-European country, e.g., Switzerland, South Korea, or Japan, and these products are meant to enter the European market you need a European Authorised Representative – an EC-Rep.
ACCORDING TO ARTICLE 11 OF THE MDR OR IVDR
European Authorised Representative for medical devices (EC-REP)
The acronym EC-Rep stands for European Community Representative. Synonyms: EU-REP, European Authorised Representative (EAR), European Authorised Representative for medical devices and in vitro diagnostics
According to Article 11 of the European Medical Devise Regulation (MDR) as well as the In-Vitro Diagnostic Medical Devices Regulation (IVDR) only after a comprehensive registration of each product or product group and a mandate for an Authorised Representative you will be able to access the European markets.
Note: Any EC-Rep as well as the actual mandate relationship between you and the authorized representative must be registered in the European Database for Medical Devices (EUDAMED).
What is an European authorised representative for medical devices?
There are four roles described in the MDR and/or IVDR and an economic operator can hold. The EC-Rep is one of them. The other three are manufacturer, importer and/or distributor.
The MDR defines the authorised representative for medical devices in Article 2(32) as follows:
‘authorised 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 under this Regulation.
Who needs an EC-REP?
Every manufacturer of medical devices and/or in-vitro diagnostics to be marketed under the MDR or IVDR does need an EC representative in order to legally place its products on the European markets.
EXPERTS FOR MEDICAL DEVICES
Reasons to work with us
Besides being awarded as one of the TOP CONSULTANTs in 2022 Nemius also got the Top-Service-Seal from the German Institute for Innovation, Sustainability and Digitalization in Hamburg. We are proud to be able to offer you our customer-oriented, competent, and digital mindset to get your medical device products certified to access the European market.
You will not only be able to tap in our well-connected network to German authorities and Notified Bodies, but be provided with a professional, timely and determined service. We are well-prepared with expertise and competence, so working with us you can save a lot of time! Contact us today and we are happy to discuss our journey together.
What are the tasks of an EC-REP?
This is clearly stated in Article 11(3) of the MDR or IVDR. It says:
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
- (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
- (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
- (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29; (d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
- (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
- (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
- (g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
- (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
At which timepoint is it best to give out such mandate to an authorised representative for medical devices?
Without having secured a mandate to an EC-Rep placing your products on the market and/or distributing them is illegal under the MDR and/or IVDR. Therefore, it is best to appoint and register an EC Representative BEFORE your devices are placed on the European market for the first time. This way you will avoid problems at customs or other authorities during shipping and importing.
Which consequences follow when not having appointed an EC-Rep?
Without an EC Representative there will most probably occurring one of the following situations:
- to protect patients from counterfeit products and to reduce risk of injury customs control will most probably refuse the import and seize (or destroy) the products.
- Your products may need to be reworked or will be destroyed.
- You may be charged with placing counterfeit products on the market.
- Depending on the risk class of the products your notified body will not issue you the needed EC certificates or even discontinue the conformity assessment procedure with you.
The authorised representative is therefore an indispensable prerequisite to access the European medical device market.
Additionally, you as manufacturer as well as your EC-Rep need to have implemented a quality management system and have a Responsible Person in place, according to Article 15 of the MDR and/or IVDR. To find out more about the obligations of a Responsible Person, click here.
How to register your European authorised representative for medical devices?
Any EC-Rep must be registered in the European Database for Medical Devices (EUDAMED). Until EUDAMED is fully operational, however, there are national databases supporting that function. Currently any EC-Rep in Germany needs to be registered in the German Medical Devices Information and Database System (DMIDS) of the Federal Institute for Drugs and Medical Devices (BfArM).
Do these regulations apply to ALL European Countries (EC)?
Yes! As the MDR and/or IVDR is an EU regulation (numbered with 2017/745 for Medical Devices and 2017/746 for in vitro diagnostic medical devices) it does apply to all member states of the European Union, thus needs to be followed in all EU countries. In all EU countries do apply the same rules and obligations for all 4 roles as declared in the regulations, such as manufacturer, distributor and/or importer as well as the authorised representative.
Is it advisable to have more than one EC-Rep?
That strongly depends on the product portfolio you wish to sell on the European market combined with the expertise of the EC Representative you have a mandate for. It can be wise, to have more than one EC-Rep in place, one for the one product group where expertise knowledge is needed and another for other product groups. Each product, however, can only have one EC-Rep!
We would be happy to discuss with you the products you like to place on the European market. Whether it is a Medical Device or an IVD, please do not hesitate to get in touch.
Apart from an authorised representative, is there an alternative to place medical devices on the European market as non-european manufacturer?
No. In order to place medical devices and in vitro diagnostic medical devices on the European market any manufacturer must have appointed an authorised representative. Those who do not comply with this must expect legal consequences from the authorities.
![[Translate to English:] Das Label des EC-REP muss Etikettierung, der Verpackung und der Gebrauchsanweisung vorhanden sein](/fileadmin/_processed_/d/1/csm_ec-rep-label_Shutterstock_1929294866_586a400293.jpg "Does the name of the EC-Rep have to appear on your product?")
Can my European authorised representative be audited?
Yes, the EC-Rep must expect unannounced audits. For this reason, the EC representative has to have processes in place to enable such audits from the relevant authorities as well as his customers (the manufacturer) at any time.
Therefore, it is imperative to have access to all required documentation at the EC-Rep´s headquarter. For instance, the authorised representative must be able to provide the latest version of the complete technical documentation of your medical devices (or in vitro diagnostic medical devices) to the Notified Body, legal and market surveillance authorities at any time.
Can I switch to another EC-Rep once I have appointed one?
Yes, Article 12 of the European Regulation 2017/745 on medical devices (MDR) or 2017/746 on in vitro diagnostic medical devices (IVDR) sets out the necessary requirements for changing your authorised representative. To change the EC representative requires a written agreement between the parties and must be notified accordingly to your Notified Body or the authorities.
Furthermore, it is necessary to make the change in the European Database for Medical Devices (EUDAMED) and/or any national databases your EC-Rep is registered in. The next authorised representative for your medical device products must be registered with name and contact details in order to hand over the mandate to that new EC Representative.
If you have any questions regarding this procedure, please contact us. We will be happy to advise you in detail!
