European standard for risk management of medical devices is amended - EN ISO 14971 2019

EN ISO 14971 2019

Two years’ back EN ISO 14971 2019 Medical Devices – Application of Risk Management to medical devices was published. Harmonized Standard EN ISO 14971 2019 has already replaced the previous standard EN ISO 14971:2012 which was only harmonized for three directives MDD, AIMDD and IVDD. There were content deviations in the Z annexes of EN ISO 14971:2012. The limitation of the coverage & the content deviation caused many problems for the manufacturer in compliance with the directives. The MDR and IVDR have significantly more comprehensive and detailed requirements for the Risk Management Process as compared to these directives.  

New Z Annexes:  

First of all, there are no any content deviations in the New Z Annexes of EN ISO 14971 2019 + Amd11:2021; which is a big relief. The European Amendment containing ‘New Z Annexes’ has been finally released and will be Harmonized in the First Quarter of Year 2022. The New Z Annexes are ZA and ZB. ZA and ZB annexes in EN ISO 14971 2019 + Amd11:2021 show a strong bond between the standard and the Risk management process. New Z Annexes state that the compliance with the standard gives the presumption of the conformance with the applicable GSPRs of the European Regulations MDR and IVDR.   

GSPRs covered by New Z Annexes:  

Z Annexes contain a Table showing which GSPRs in Annex 1 are covered i.e. Annex ZA and ZB show the relationship between the GSPRs in Annex 1 of each regulation with the clauses of Risk Management standard of Medical Devices (EN ISO 14971 2019).  

Read More – EN ISO 14971 2019

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If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

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 CDSCO Manufacturing License 

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TURNKEY PROJECT CONSULTANT 

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 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

CDSCO Registration FAQs 

CDSCO Registration FAQs

Who can register for CDSCO online portal?  

Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary, Cosmetics, Ethics Committee, Formulation R&D Organization, BA/BE Approved Sites, Sponsors(BA/BE & CT)  

How will I login to CDSCO online portal ? 

Frist go to homepage and check on ‘sign in’ under with you will get a link named ‘Sign up Here’ then fill the details and upload the document required with a proper official email id on with all the correspondence activity’s would be done. After your email id gets verified then check further action on register email id. Where you are been required to send the hard copy of document submitted. After which you will get your login credentials on register email id. 

I am not able to receive Email or SMS service from CDSCO Portal?   

Check your Junk/Spam folder, so if you receive mail in junk/spam folder then save “ cdscoonline-noida@cdac.in” in your contacts and if not, then please contact to Administrator by “Report a problem” section on home page of CDSCO Portal.  

 If you have selected the option to receive SMS at the time of registration then only you will receive SMS alerts. If done check DND (Do not disturb) settings in your phone. If not, then please contact to Administrator by “Report a problem” section on home page of CDSCO Portal.   

Read More – CDSCO Registration FAQs

Read More Article – 1. Orthopedic Implants Manufacturing2. disposable syringe manufacturers3. Dental Implants Manufacturing4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no –  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

 cdsco registration

 FDA 510k Clearance

 ce mark medical device

 CDSCO Manufacturing License 

CDSCO import license 

TURNKEY PROJECT CONSULTANT 

medical device manufacturing

 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

EU MDR Economic Operator

For the medical device manufacturer it is important to understand the role of EU MDR economic operator .These operators are also referred with the acronym MAID. The role of economic operator is tied to legal liability so one should understand how they fit in economic operator framework. 

Who are EU MDR economic operators?   

Economic operator As per MDR / IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3). The entities which supplies goods, services in context of that market is termed as operator. 

EU MDR Economic operators are considered as   

  • Manufacturer  
  • Authorised representative   
  • Importer  
  • Distributor  

As per article 22 (1) the entity that combines the devices which are CE Certified and   

  • Devices that bear the CE marking  
  • IVD medical devices bearing CE marking (EU IVDR 2017/746)  
  • Compliant products used within a Medical Procedure or which presence on the pack is justified.  

Read More – EU MDR economic operator

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QMS perspective for Drug device combination

To begin with, we will first understand QMS. Quality Management system is a structured process and procedure which covers all aspects of designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. This Article explains QMS perspective for drug device combination for a manufacturing company. Combination product regulated by FDA Guidance. Combination product means products which are combining drugs and devices such as pre-filled syringes, catheters with antimicrobial coatings, infusion pumps etc. ISO 13485 certification is mandatory and is globally accepted by different regulations. Whether you are looking to operate internationally or expand locally. ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. 

QMS perspective for drug device combination and challenges: 

Regulations play crucial role   for drug device combination as drugs are regulated by act 21CFR210/211 whereas medical devices are regulated by the act 21CFR 820, Human cells, tissues/Ps by 21 CFR1271 etc. For the commercialization of product, it is necessary for the organization to harmonize their product development with Quality management system. There is no clear explanation neither from MDR2017/745 nor from medical product directives for human use which can give a clear idea to reader about which requirement of MDR would or would not apply to device when combined with medical product. 

Read More –  QMS perspective for Drug device combination (operonstrategist.com)

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Contact details –

Phone  no –  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

 cdsco registration

 FDA 510k Clearance

 ce mark medical device

 CDSCO Manufacturing License 

CDSCO import license 

TURNKEY PROJECT CONSULTANT 

medical device manufacturing

 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

Medical Device Registration in Australia

Medical Device Registration in Australia Process: 

Therapeutic Goods Administration (TGA) oversees regulation of medical devices in Australia through Australian Regulatory Guidelines for Medical Devices (ARGMD) and these guidelines closely resemble with the regulations put into place by the European Union. To gain access to the Australian market, medical device and IVD manufacturers need to include their products in the Australian Register of Therapeutic Goods (ARTG). Medical devices are obliged to be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia, imported into Australia or exported from Australia. currently TGA recognises CE marking, means companies who have already acquired the European market can easily meet TGA requirement. 

Classification of Medical Devices in Australia  

In Australia, medical devices are classified as per the Australian Therapeutic Goods (Medical Devices) Regulations 2002. Medical devices are classified with respect to their intended purpose. Particularly, the classification rules take into consideration the degree of invasiveness in the human body, the duration use, location of use, and whether the device relies on a source of energy other than the body or gravity.   

Read More –  Medical Device Registration in Australia 

Read More Article – 1. Orthopedic Implants Manufacturing2. disposable syringe manufacturers3. Dental Implants Manufacturing4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no –  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

 cdsco registration

 FDA 510k Clearance

 ce mark medical device

 CDSCO Manufacturing License 

CDSCO import license 

TURNKEY PROJECT CONSULTANT 

medical device manufacturing

 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

How do FDA Medical device recalls?

What is the process of Medical device recalls? 

If the manufacturer or importer fails to recall their product FDA may issue recall order under 21CFR 810. Medical devices recall usually conducted voluntarily. Recall means removing or correcting the product. According to the definition of FDA, 

Recall means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.  

Recall by classification: 

The FDA will give a recall classification based on this determination, such as Class I, Class II, or Class III, to determine the relative level of health threat of the product being recalled or considered for recall. Types of recall : 

Class 1recall can cause a severe impact on patient’s life, they can lead to death so these products should recalled voluntarily by the manufacturer. The impact of Class 2 devices may or may not be life threatening such as medical  implants, class 3 recall may not likely to cause adverse health consequences . 

Read More – Medical device recalls

Read More Article – 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone no –  9325283428

Mail  – dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

 cdsco registration

 FDA 510k Clearance

 ce mark medical device

 CDSCO Manufacturing License 

CDSCO import license 

TURNKEY PROJECT CONSULTANT 

medical device manufacturing

 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

QMSR- Quality Management System Regulation

This Blog speaks about harmonization of FDA QSR and ISO 13485. Those who are new to the industry probably have so many questions like How do we start? Which Regulations need to follow? what is QSMR? 

To begin with, we will first understand QMS. Quality Management system covers designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes.

QMSR-(Quality Management system regulation Explained) 

QMSR Explained: What FDA QSR and ISO 13485 Harmonization means for Medical Device Companies 

After the Four years, the US Food and Drug Administration (FDA) signalled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016.  

 As per the FDA’s rule proposed on February 23,2022 for the new QMSR, The proposed QMSR will be the outcome of integrating the FDA’s Quality System Regulation (QSR) regulations for current Good Manufacturing Practices (cGMP) with ISO 13485:2016, the international consensus standard for medical device quality management systems. According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards. 

Read More – QSMR

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1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

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FDA Registration FAQ’s

 FDA is an agency within the US health and welfare department, a regulatory body which provides some guideline for setting up the plants of medical devices. FDA registration FAQs

What is FDA and FDA Registration? 

FDA is Food and Drug Administration Agency formed for consumer’s safety and security. Any medical device manufacturer who wish to sell their product in USA market or the exporter’s and importer’s at their initial stage should register them with FDA. The registration of product depends upon the Class of the device. we the team of Operon strategist help and guide medical device manufacturer in FDA Registration process. 

What are the Roles and responsibilities of FDA? 

FDA’s prime intention is to protect public health by ensuring safety and security. FDA always take initiatives for innovation which favors the public health and safety. 

What type of product needs FDA approval? 

Whether I need FDA’s Approval or not? 

Are FDA and ISO same? 

On what basis medical devices are classified? 

What is cost of FDA approval? 

How will I get FDA approval? 

Is FDA approval and FDA registration same? 

Is FDA registration process time taking? 

Read More – FDA registration FAQs

Read More Article – 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone no –  9325283428

Mail  – dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

 cdsco registration

 FDA 510k Clearance

 ce mark medical device

 CDSCO Manufacturing License 

CDSCO import license 

TURNKEY PROJECT CONSULTANT 

medical device manufacturing

 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

Roles of PRRC (Person Responsible for Regulatory Compliance)

EUMDR introduces new requirements for the medical devices manufacturers, which explains the Roles of PRRC. according to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye on regulatory compliance. PRRC’s plays vital roles and responsibilities in setting up the plants for manufacturing medical devices. 

The PRRC’s are the authorized person who should have some specific qualification and experience .EU has published new rules and regulations for   medical devices manufacturers that, these companies or organizations should have PRRC with them to look out the matter of regulations and policies PRRC is responsible for regulatory compliance Article 15(1) of MDR and IVDR has outlined some specific prerequisite for PRRC. 

The medical device manufacturer who wishes to sell/ supply their device in European Union they must have at least one Person Responsible for Regulatory Compliance (PRRC) at their site of disposal.  

Who can be PRRC and what are their Roles and responsibilities? What are the Roles of PRRC and Responsibilities of PRRC?  Is that authorised representative requires PRRC?  

Read More – Roles of PRRC

Read More Article – 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

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IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS

The drug -device combination (DDC) products are the therapeutic or diagnostic products that combine drugs, devices or biological products which leads to safe and effective treatments. It helps in targeted drug delivery, localized drug administration and individualized medicine therapy. With the advancement in technology drug-device combination products have developed a unique form of medicinal products that has cardiovascular, neurological, orthopaedic applications. The widely used DDC combination products are autoinjectors, inhalers, antibiotic-loaded bone cements, bioartificial liver devices, pre-filled nebuliser, pre-filled pen, pre-filled syringe, transdermal patch etc. 

EUROPE’S MDR AND CE MARKING  

The European Medicines Agency (EMA), has put forth the guidance for compliance issues for manufacturers of combination products with drug and medical device components. For drug-device combination products to be marketed in the European market it should undergo conformity assessment results or CE mark issued by notified bodies. For the devices that do not have CE marking the manufacturers need to submit conformity regarding components to MDR requirements from the notified bodies. 

Read Article 

IMPLICATION OF MDR ARTICLE 117 FOR DRUG-DEVICE COMBINATION PRODUCTS

The medicinal product and the medical device are combined to form an integral product and are subjected to EU Medical Device Regulation (MDR) 2017/745. The European Commission under the medical device regulation (MDR) has introduced article 117 which states the requirements for manufacturers for placing drug-device combination products into the market. 

Read More – Drug -device combination (DDC) products 

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1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

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