Hi friends!!!
In our previous blogs, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation - Part 1
EU MDR Technical Documentation - Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification - Part 1
EU MDR Unique Device Identification - Part 2
EU MDR Chapter & Articles - Part 1
EU MDR Chapter & Articles - Part 2
EU MDR Procedure for Custom-Made Devices
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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