The advantage of getting a Single Registration Number early is to include it in relevant regulatory documentation (such as the Declaration of Conformity, Technical Documentation, Certificates issued by a Notified Body, and Certificate of Free Sale) without the need of updating them at a later stage as the SRN will remain stable. The SRN guarantees an EU-wide unique identification for economic operators (also outside of EUDAMED). The registration as an economic operator in EUDAMED is also a precondition to start using other modules of the database upon their availability (such as the one for UDI and Device registration).

• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)
• Council Directive 93/42/EEC on Medical Devices (MDD)
• Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVDMD)

Thus, the two following Regulations were established in 2017 to improve the control of medical devices in the EU Market: the efficiency of medical devices that are placed in the European market.

Thus, the two following Regulations were established in 2017 to improve the control on medical devices in the EU Market:

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

These Regulations will replace the existing directives after a transition period:

- for the MDR it is going to be May 26, 2021

- for the IVDR it is going to be May 26, 2022

However, to ensure  high level of health and safety protection for EU citizens using these products

• the free and fair trade of the products throughout the EU

The European Commission has launched a new dedicated webpage for collecting all necessary information on actor registration in EUDAMED.

The registration platform will be open from December 1, 2020 when this first module of the future European Medical Device Database will be launched – you can access the Actor Registration User Guide. EU and non-EU Manufacturers, authorised representatives, importers and system/procedure pack producers acting on the field of medical devices (including in vitro diagnostic medical devices) can apply for single registration number (SRN) already ahead of the Date of Application of the MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746). Infographic: Actor roles and SRN, Actor registration request process.

The advantage of getting a Single Registration Number early is to include it in relevant regulatory documentation (such as the Declaration of Conformity, Technical Documentation, Certificates issued by a Notified Body and Certificate of Free Sale) without the need of updating them at a later stage as the SRN will remain stable. The SRN guarantees an EU-wide unique identification for economic operators (also outside of EUDAMED). The registration as an economic operator in EUDAMED is also a precondition to start using other modules of the database upon their availability (such as the one for UDI and Device registration).

It is still to be confirmed which Member States will accept the registration of an economic operator only in EUDAMED, and which will maintain parallel their current national registration process and platform.

The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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