Friday, March 29, 2024

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 instructions for use as per EU MDR 2017/745.

Let's get into the topic.

Instructions for use

In EU MDR 2017/745, Annex I – “General Safety and Performance Requirements”, Chapter III – “Requirements regarding the information supplied with the device”, section 23.4 provides requirements about information in the Instructions for use.

Let’s discuss about few important information’s to be provided in the Instructions for use as per EU MDR 2017/745.

The Instructions for use shall contain the following details, but not limited to the following:

Medical Device’s intended purpose with information about indications, contra-indications, target patient groups, intended users as appropriate.

Information that informs the user and/or patients using the medical device about the warnings, precautions, contra-indications, relevant measures to be taken and limitations in the usage of medical device.

Information about any residual risks, contra-indications & undesirable side effects, including the information to be conveyed to the patient.

If applicable, information allowing healthcare professionals to verify whether the device is suitable for use and to select the corresponding software and accessories. Other information required by the user to use the device appropriately.

Information about requirements with respect to any special facilities and trainings or qualifications of the medical device users and/or other persons.

If applicable, any specifications of the Clinical Benefits to be expected from the medical device and links to the summary of safety and clinical performance. The Performance Characteristics of the device shall also be specified in the Instructions for Use.

Instructions to follow in the event of sterile packaging of the medical device being damaged or unintentionally opened before use. Appropriate instructions for sterilization, if the medical device being supplied is non-sterile with the intention of getting sterilized before use.

Information related to verifying whether the medical device is installed properly and is ready to perform safely, as intended by the manufacturer of medical device.

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If the medical device is intended to be used together with other devices and/or general-purpose equipment’s, such devices shall be identified in the instructions for use to obtain the safe combination. In case if any restrictions to the combinations of device and equipment, it needs to specified in instructions for use.

If the medical device emits radiation for medical purposes, Information about the nature, type and if appropriate, intensity and distributions of the radiation emitted by the medical device shall be provided in the Instructions for Use. Information for protecting the user, patient and other persons from the unintended radiation during the use of medical device shall also be provided

If the medical device is reusable, then information about appropriate processes for reuse shall be specified in the instructions for use. Information shall also be provided to identify when the medical device should not be reused. E.g.: Maximum number of allowable reuses.

If the medical device is single use device, information about the risks that can happen if the device is re-used, shall be captured in the instructions for use.

Information about the warnings or precautions that needs to be taken to facilitate the safe disposal of medical device, it’s accessories and consumables shall be mentioned.

The circumstances in which the lay user needs to consult with healthcare professionals shall be specified, if the medical device is intended to be used by lay users.

Date of issue of the instructions for use shall be specified. If the instruction for use is revised, the revised date and identification of the latest revision shall be specified.

Notice to the user and/or patient shall be provided in the instructions for use, stating that any serious incident with respect to the device should be reported to the manufacturer of the device.

Now I hope you have acquired some basic knowledge about the requirements of instructions for use 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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

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Check out for the below blogs about IEC 62304 & IEC 60601-1.

IEC 62304 Software Configuration Management & Problem Resolution Process

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IEC 62304 Software Architectural & Detailed Design

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Saturday, February 3, 2024

EU MDR Scrutiny Procedure

Hi friends!!!

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

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

EU MDR Chapter & Articles - Part 2

EU MDR Clinical Investigation

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 the 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.