Wednesday, June 30, 2021

EU MDR Assessment Routes

Hi friends!!!

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Assessment Routes.

Let’s get into the topic.

EU MDR 2017/745 MEDICAL DEVICE

CLASSIFICATION

As per EU MDR 2017/745, the Medical Device is classified as following.

1. Class I.

2. Class Is Sterile, Im Measuring function, Ir Reusable.

3. Class IIa.

4. Class IIb.

5. Class III.

Each of the above classified device have separate assessment routes.

Let’s discuss in detail about assessment routes.

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EU MDR 2017/745 ASSESSMENT ROUTES

Class I

The conformity assessment for Class I Medical Device shall be done based on Article 52, Clause 7. The Article 52, Clause 7 states the following.

Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.

Class Is, Im, Ir

The conformity assessment for Class Is, Im, Ir shall also be done based on Article 53, Clause 7. The Article 52, Clause 7 states the following about Class Is, Im, Ir.

If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX QMS along with Technical Documentation set out in Annexes II and III or in Part A of Annex XI Production Quality Assurance along with Technical Documentation set out in Annexes II and III.

Class IIa

The conformity assessment for Class IIa Medical Device shall be done based on Article 52, Clause 6. The Article 52, Clause 6 states the following.

Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4, Chapter II of that Annex of at least one representative device for each category of devices.

Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Part A, Section 10 Production Quality Assurance or Part B, Section 18 Product Verification of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.

Class IIb

The conformity assessment for Class IIb Medical Device shall be done based on Article 52, Clause 4 and Clause 5. The Article 52, Clause 4 and Clause 5 states the following.

Clause 4

Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.

However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.

Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.

Clause 5

Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.

Class III

The conformity assessment for Class III Medical Device shall be done based on Article 52, Clause 3. The Article 52, Clause 3 states the following.

Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.

Now I hope you have acquired some knowledge about EU MDR 2017/745 Assessment Routes. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

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Friday, June 11, 2021

EU MDR Timeline, Chapter and Annex

Hi friends!!!

EU MDR 2017/745 is live now. And it 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.

Let’s get into the topic.

WHY EU MDR 2017/745?

The incidents like PIP Breast implant scandal forced medical device regulators to think about revising the medical device directive. It resulted in the European Union Medical Device Regulation EU MDR 2017/745.

The European Union adopted the new Medical Device Regulation called EU MDR 2017/745, replacing the two existing directives, the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. The evolution of technology in the field of healthcare has forced the formation of new medical device regulation. It is also aimed to overcome certain shortcomings in earlier directives.

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WHAT IS EU MDR 2017/745 TIMELINE?

EU MDR 2017/745 entered into force on 26 May, 2017.

Beginning date of application for EU MDR 2017/745 is on 26 May, 2021. From this date, new devices entering into the market have to be certified under EU MDR 2017/745. Certificates of devices which are already issued under MDD before this date may remain valid for additional 3 years till May 26, 2024.

From 26 May, 2024 – 25 May, 2025 the MDD Devices which are already placed on the market before may continue to be made available.

Last date for putting devices into market according to MDR is on 26 May, 2025. After this date, all devices placed on the market must be in conformity with the EU MDR 2017/745. The devices certified under the EU MDD can no longer be sold or distributed.

WHAT ARE THE CHAPTERS IN EU MDR

2017/745?

The following are the chapters in EU MDR 2017/745.

Chapter I: Scope and Definitions.

Chapter II: Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement.

Chapter III: Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices.

Chapter IV: Notified bodies.

Chapter V: Classification and conformity assessment.

Chapter VI: Clinical evaluation and clinical investigations.

Chapter VII: Post-market surveillance, vigilance and market surveillance.

Chapter VIII: Cooperation between Member States, Medical Device Coordination Group, expert laboratories, expert panels and device registrars.

Chapter IX: Confidentiality, data protection, funding and penalties.

Chapter X: Final provisions.

WHAT ARE THE ANNEXES OF EU MDR

2017/745?

The following are the Annexures of EU MDR 2017/745.

ANNEX 1: General safety and performance requirements.

ANNEX II: Technical Documentation.

ANNEX III: Technical Documentation on post market surveillance.

ANNEX IV: EU Declaration of conformity.

ANNEX V: CE Marking of conformity.

ANNEX VI: Information to be supplied with the registration of devices and economic operators in accordance with article 23 and data elements of UDI in accordance with article 22.

ANNEX VII: Minimum requirements to be met by notified body.

ANNEX VIII: Classification criteria.

ANNEX IX: Conformity assessment based on full quality assurance and design examination.

ANNEX X: Conformity assessment based on type examination.

ANNEX XI: Conformity assessment based on production quality assessment.

ANNEX XII: Custom made devices.

ANNEX XIII: Minimum content of certificates issued by a notified body.

ANNEX XIV: Clinical evidence and post market follow up.

ANNEX XV: Clinical Investigations.

ANNEX XVI: Products without intended medical purpose.

ANNEX XVII: Correlation table.

Now I hope you have acquired some knowledge about EU MDR 2017/745 Timeline, Chapter and Annex. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.