EAR(EU) Service

European Authorised Representative

An Authorized representative is either a person or an entity who is responsible for placing the medical devices of a non EU manufacturer in EU market under his own name.Does all the communication with the notified body and register his devices with competent authority.

European representative should be chosen with care as is responsible for activities like product registration and Products Recall, Vigilance, Market Surveillance etc. He also monitors the various post marketing and vigilance issues related to product and are the contact person on your behalf who is contacted by European authorities in case of emergencies.

 

We have legal offices in Netherlands and UK for providing this services

Medical Device Regulation – The new MDR EU 2017/745

The New Medical device Regulation comes into effect on 26th May 2021- commonly referred to as “date of application”. similiarly the date of application for the new IVDR is 26th May 2022.The MDR reclassifies certain medical devices and has a wider scope than the earlier  MDD. It introduces an additional pre-market consultationprocedure for certain high-risk medical devices. For IVDs, the biggest change concerns the risk classification of in vitro diagnostic devices and the role of Notified Bodies. As a result, around 85% of all IVDs will need oversight from Notified Bodies, compared to 20% under the Directive

There is a new clinical evaluation consultation procedure for Class III implantable devices and certain Class IIb devices, to be carried
out by an independent expert panel. The Notified Body will have to take into consideration the scientific opinion expressed by the
expert panel.

European Authorised Representative

Unique Device indicator – UDI

The new MDR article 24 introduces -A completely new feature   of Unique Device Identifiers (UDIs). The UDI will allow all stakeholders to access basic information on devices through the European Database on Medical Devices (EUDAMED).Each MD or IVD and, as applicable, each package will have a UDI composed of two parts. The first part is a device identifier
(UDI-DI) specific to a manufacturer and a device. The second part is a production identifier (UDI-PI) – such as a lot number
or a serial number – to identify the unit of device production and, if applicable, the package. Every level of packaging will be
uniquely identified.For both Regulations, the deadline for assigning UDIs is the respective DoA. However, the obligation to affix the UDI on the
labelling will be implemented in three stages