Hi friends!!!

In our previous blogs, we have discussed about the following topics.

EU MDR 2017/745 is live now. And it is the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745. In today’s blog, we are going to discuss about the requirements of Certificates issued by a Notified Body as per EU MDR 2017/745.

Let’s get into the topic.

Certificates issued by a Notified Body:

In EU MDR 2017/745, Annex XII provides the requirements for Certificates issued by a

notified body.

General Requirements:

The following are the general requirements for the Certificates issued by a notified body.

The Certificates issued by a Notified Body shall be in one of the official languages of Union. And each Certificate shall only be issued to one medical device manufacturer.

Only one Conformity Assessment Procedure shall be referred in the Certificate.

The name and address of the medical device manufacturer provided in the certificate shall match with the details registered in electronic system in accordance with
article 30 of EU MDR 2017/745.

The device or devices covered in the scope of the certificates shall be unambiguously identified.

EU Technical Documentation assessment certificates, EU Type Examination certificates and EU Product Verification certificates shall include the clear identification of the name, model & type of the medical device or devices, intended purpose as identified in the IFU by the manufacturer, risk classification, basic UDI-DI in accordance
with Article 27(6) of EU MDR 2017/745.

EU Quality Management System certificates and EU Quality Assurance certificates shall include the identification of the medical device or devices, risk classification. In case
of Class IIb devices, the intended purpose shall also be included.

On request, the notified body shall be able to identify, which devices are covered by the certificate. The notified body shall also set up a system that enables the determination of the medical devices and their classification covered by the certificate.

When a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and information about its date of issue along with the identification of changes.

Minimum Content of the

Certificates:

The following are the minimum contents needed in the Certificates issued by a notified body.

The name, address and identification number of the notified body issuing the certificate.

The name and address of the manufacturer of the medical device. If applicable, the name and address of the authorized representative shall also be provided.

The Unique number for identifying the certificate. And the date of issue & expiry.

Data needed for the unambiguous identification of the device or devices as specified in above general requirements.

The SRN of the manufacturer of medical device, if already issued.

Reference to any previous certificates as described in above general requirements, if applicable.

Reference to EU MDR regulation and relevant annex by which the conformity assessment has been carried out shall be provided in the certificate.

Reference to parts of technical documentation or other certificates shall be provided in the certificate, if applicable.

Reference to examinations and tests performed shall be provided in the certificates. For example, Reference to relevant harmonized standards, test reports & audit reports etc.

The legally binding signature of the notified body issuing the certificates shall provided in accordance with the national law.

If applicable, the information about the surveillance by the notified body shall also be provided in the certificate.

Now I hope you have acquired some basic knowledge about the requirements of Certificates issued by a Notified Body as per EU MDR 2017/745. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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