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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 Scrutiny Procedure of EU MDR 2017/745.

Let’s get into the topic.

SCRUTINY PROCEDURE

The Scrutiny procedure in EU MDR is intended to improve the overall quality of conformity assessments performed by the notified body for high-risk category devices. The Scrutiny is for additional review & improves transparency in the conformity assessment process.

As per Article 54 & 55, manufacturers of Class III Implantable Devices & Class IIb active devices intended to administer or remove medicinal products are subjected to scrutiny.

Apart from Manufacturers of Medical Devices, Scrutiny also impacts the Notified Bodies, Competent Authority, MDCG & Expert Panel.

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The following are the roles & responsibilities of Manufacturers, Notified Body, Competent Authority, MDCG & Expert Panel:

Manufacturer:

The Manufacturer of Medical Device submits the Conformity Assessment documentation & Summary of Safety & Clinical Performance to the Notified Body.

Notified Body:

The Notified Body performs conformity assessment of the documentation submitted by the manufacturers of the Medical Device. As per “Article 55, Mechanism for scrutiny of conformity assessments of certain Class III & Class IIb devices”, the Notified Body notifies the competent authority about the certificates it has granted by performing conformity assessment in accordance with Article 54(1). Such notification shall take place via electronic system as referred in Article 57. The notification shall include the following details.

The Summary of Safety and Clinical Performance in accordance with Article 32.

Conformity Assessment report by the notified body.

The Instructions for Use as referred in Section 23.4 of Annex I.

If applicable, scientific opinion of the expert panels as referred in Section 5.1 of Annex IX or Section 6 of Annex X. If Notified Body decided not to follow the advice from Expert Panel, an appropriate justification shall also be included.

Competent Authority:

The Competent Authority determines the need to perform the additional scrutiny of the Notified Bodies Conformity Assessment of Documentation. The Competent Authority makes such decisions in accordance with the following articles.

Article 44: Monitoring & re-assessment of notified bodies

Article 45: Review of notified body assessment of technical documentation and clinical evaluation documentation

Article 46: Change to designations & notifications

Article 47: Challenge to the competence of notified bodies

Article 94: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

The Competent Authority also coordinates with MDCG, if required.

Medical Device Coordination group (MDCG):

The MDCG directs the scrutiny process & coordinates with the expert panel, if required.

Expert Panel:

The Expert Panel provides scientific expertise & expert opinion on the conformity assessment. The Expert Panel can advise restrictions to medical indications or intended purpose, can limit the certificate validity, propose updates to PMCF Plans, IFU’s, SSCP.

Article 54: Clinical Evaluation consultation procedure for certain class III and class IIb devices

When performing a conformity assessment of Class III & Class IIb Medical Devices, apart from the procedures specified in “Article 52, Conformity Assessment Procedures”, the notified body can also follow the procedure regarding Clinical Evaluation Consultation as specified in Section 5.1 of Annex IX or Section 6 of Annex X.

The notified body shall notify the competent authority via electronic system as referred in Article 57 of whether the above-mentioned procedure of article 54 is applied or not. The notification shall be accompanied by clinical evaluation assessment report.

Now I hope you have acquired some basic knowledge about Scrutiny Procedure 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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