single registration number services

Single Registration Number Services, It is a set of alphanumeric characters that uniquely identifies each economic operator (EO) in EUDAMED.

History Of SRN

The SRN is a unique identification number that guarantees the identity of all economic operators in the European Union. It is generated after a request is assessed and approved by the competent national authority. To obtain an SRN, every economic operator has to register in the EUDAMED database. If an economic operator is not in the EU, they must have an authorized representative registered with the agency.

An SRN is use to recognize every economic operator in the European Union instantly. It is require for numerous documents such as Declaration of Conformity (DoC) forms and certificates. 

The SRN is necessary before any CE marking process can begin and before any medical device can be placed on the market. Moreover, it is also require for access to EUDAMED, which is a database where users can submit their products. The data submit in the database can be share publicly.

How to use the EUDAMED SRN

An SRN, or Single Registration Number, is a unique number assign to every economic operator in the EUDAMED database. It is use for various purposes, including technical documentation, reporting incidents, bidding, and procurement procedures. To use an SRN, an economic operator must be a legal manufacturer or an authorized representative of a manufacturer. To fully utilize the EUDAMED SRN, the actor module must be available. 

Who Needs An SRN?

An SRN is a number assign to an actor by an organization. A company needs one for each person or role it is responsible for. For example, a manufacturer based in the EU needs one SRN for every person who imports and sells devices. Another actor needs one for each role they play, including that of an authorized representative.

SRNs are require for specific clinical and research studies, including Periodic Safety Update Reports and field safety notices. They are also use in conformity assessment requests. However, companies selling legacy medical devices can voluntarily obtain an SRN. 

In addition to manufacturers, SRNs can be assign to authorize representatives, importers, and system/procedure pack manufacturers. 

Structure of Single Registration Number SRN

As SRN is unique alphanumeric characters set. It has a unique structure as well and is divide into three parts. 

The first part identifies/represents the country code, i.e. “PK” for Pakistan. The second part represents the role of economic operator, i.e. “MF” for manufacturer and the third and last part comprises of nine numeric digits. The exemplary format is as follows;
“PK-MF-000000001”.

How can SRN Numbers Benefit Manufacturers?

The Single Registration Number (SRN) is a unique identification number that guarantees a single EU-wide identity for economic operators. The new number is available to EU and non-EU manufacturers, who only need to register their devices once. This number will be use for EUDAMED-regulated medical devices.

To obtain an SRN, a manufacturer must register their product with Eudamed. Once this is done, the manufacturer is issued an SRN that can be used for compliance assessment and Eudamed access. The SRN also fulfills a manufacturer’s Article 29 obligations as per EU MDR 2017/745. With the help of SRN a company can be identified/searched directly from EUDAMED by clients, healthcare providers, regulators and general public as well.

Conclusion

In the EU, a Single Registration Number is require to law for all economic operators. This includes manufacturers, importers, and authorized representatives.