Category Archives: Medical Devices

Medical Device Industry and COVID-19: Regulatory Modifications to Consider

Medical Devices, , , , , , , , , , ,

Background

The COVID-19 outbreak is a public health crisis that this generation has never seen before and has presented itself as an unprecedented challenge to the health industry including the Medical Device and Regulatory framework.

There is tremendous burden being faced by first responders and health institutions. Simultaneously, there is increasing pressure on national authorities, EU member states, and economic operators to supply vitally important medical devices at the time of adoption of Regulation (EU) 2017/745.

The unanticipated crisis has had a significant impact on placing devices on the market in the Union while halting the designated work of the notified bodies. The commission recognizes the role of Personal Protective Equipment (PPEs) such as medical gloves, surgical masks, and equipment for intensive care in the current pandemic and has therefore decided to prioritize the demands of such equipment thereby avoiding any potential market disruption.

MDR defers till 2021

Therefore, the European Commission released a proposal earlier in April to defer without any alterations to the guidelines, the enforcement of the EU Medical Devices Regulation (MDR) for a year, applicable from May 26th, 2020. However, the commission made no deferments for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022. The aim of the deferment has been to ease the pressure on the medical fraternity to be able to cope and focus with the current crisis and minimize risk to medical professionals.

National Derogation

In scenarios of a public health crisis, such as COVID-19 the Regulation (EU) 2017/745 allows the commission to extend the validity of a national derogation for a limited period of time in exceptional cases for member states in response to address Union-wide shortages of vitally important medical devices in an effective manner.

The Commission has agreed with the European standardization organization to make originally copyright standards (including EN 149 and 14683) freely and fully available by the national standardization bodies. Manufacturers can download a copy for free from the online catalogues of the national standardization bodies.

Furthermore, Directives 90/385/EEC and 93/42/EEC of the regulation empower national authorities on duly justified requests to place medical devices on the market for whom relevant conformity assessment has not been completed but substantial evidence is available to prove interest of public health, patient safety, and health.

Market approval of devices without CE marking

In exceptional circumstances, products can be placed on the market even if no CE marking has been affixed upon them, given that the following conditions are fulfilled:

  • The products manufactured are in accordance with one of the EN standards or other standards referred to in the WHO guidelines
  • The products are part of a purchase organized by the relevant Member State authorities;
  • The products are only made available for the healthcare workers;
  • The products are only made available for the duration of the current health crisis; and
  • The products are not entering the regular distribution channels and made available to other users.

This approval, may bring some relief from the intense pressure on manufacturers to complete the MDD/AIMDD work by giving them an additional year while ensuring devices reach hospitals. Meanwhile, the European parliament and the Council continue to work together to adopt the legislation as mandated implementation date.

Take home message

It is important to note and acknowledge that the framework of manufacturers, regulatory bodies, and agencies continue to work on collaborating and collectively contributing in ensuring that medical devices are used safely amongst patients in this evolving pandemic.

Turacoz Healthcare Solutions understands medical device regulatory requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].

Borderline Medical Devices – European Commission Update (December 2017)

Medical Devices, , ,

When a device seems to fit onto the definitions of two or more product types, and cannot be clearly classified as a medical device, an in vitro diagnostic medical device, or an active implantable medical device, it is referred to as a borderline medical device. The 18th version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (Borderline Manual) was issued by the European Commission’s Medical Devices Expert Group (MDEG) on Borderline and Classification in December 2017. The manual complements MEDDEV 2.1/3 Rev. 3, which provides guidance on borderline products and other medical devices that incorporate pharmacological or biological substances. The appropriate classification of a medical device is important as it determines the device’s authorization process and marketing strategy. From a regulatory standpoint, the classification is usually based on its primary mode of action, intended use, and product claims.

The updated Borderline Manual includes recommendations on a total of 94 devices, including guidance on the classification of 12 additional product types; however, these recommendations are not legally binding. It is important to note that the decisions on the classification of a product remain a competence of the Member States, which may lead to different interpretations among different countries within the EU. However, to ensure a uniform approach, difficult cases may be discussed in the informal MDEG; the consensus statements from this meeting are published in the Borderline Manual.

The revised Borderline Manual indicates that the following products should generally be classified as medical devices:

  • Mobile application for the assessment of moles (Class I)
  • Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa)
  • Alum styptic pencils (Class IIa)
  • Dura guard for use with a craniotome (Class III)
  • Heart bypass cannulae (Class III)
  • Tissue expanders used in the breast (Class III)

On the contrary, the following products should, in principle, not be considered as medical devices:

  • Mobile application for managing pictures of moles
  • D-mannose for the prevention of urinary tract infections
  • 8-MOP solution in extracorporeal photochemotherapy
  • Products intended to reduce the effect of alcohol
  • Radiation shields
  • Microplate washers

It is important to note that based on criteria proposed by the Court of Justice of the European Union (CJEU) for borderline determinations, each product’s assessment should include several elements and be very factual; however, the guidance provided in the Borderline Manual often lacks such a detailed and balanced review. Moreover, some of the positions taken in the Borderline Manual may require reconsideration due to potential reclassifications brought by new European Commission Regulations. The new Regulations broaden the definition of a medical devices and also include some products without medical purpose within the purview of the new rules (especially products for aesthetic use). Although changes introduced by the new regulations may help resolve some of the existing borderline questions, divergent views on the classification of more complex products may persist.

Turacoz Healthcare Solutions, a medical communication company, specializes in various kinds of medical writing documents (Publication, Regulatory and Medico marketing) which covers a vast arena of clinical trials, drugs, medical devices, health economics and outcome research, observational studies etc.  We take pride in providing customized, guideline compliant documents which are well within the committed timelines.

Medical Devices in Healthcare: Their Classification System and The Marketing Approval Process

Medical Devices

Introduction

Medical device is an essential part of healthcare system. It is utilised for diagnosis, prevention and treatment of the disease as well as for patient care. It covers a broad range of products, starting from simple bandage to drug delivery pumps. Over the past two decades, the demand of safe and effective medical devices has increased tremendously. This has been achieved by constantly updating and improving the regulatory framework and implementing them in the process. Moreover, the regulatory authorities across the world are working towards smoothening of the process of registration of the medical devices.

Medical devices have different classification systems and marketing approval processes for different regions. The classification systems and marketing approval processes for United States of America (USA), Europe (EU) and Canada have been discussed below.

United States of America

The medical devices, in USA, are regulated by US Food and Drug Administration (USFDA), while the law, 21 CFR (code of federal regulation), describes the regulations of medical devices. FDA’s Centre for Devices and Radiological Health (CDRH) regularly monitors trends that point towards future product development and is responsible for pre- and post-market supervision of devices in US.

Classification of medical devices

US classifies medical devices into three categories:

  1. Class I General Controls
  • With Exemptions
  • Without Exemptions
  1. Class II General Controls and Special Controls
  • With Exemptions
  • Without Exemptions
  1. Class III General Controls and Premarket Approval

The USFDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. A panel is assigned to determine the class of medical device and decides for the exception applicable to the device.

Marketing Approval Process

Firstly, the medical devices are classified according to the FDA searching database meeting the requirements of Quality system regulation (QSR) for which Quality management system (QMS) is implemented according to the 21 CFR part 820. Clinical trial data are submitted for some of the devices of class II and all the devices of class III followed by submission of Investigational Device Exemption (IDE) report followed by submission of 510(K) premarket notification or premarket approval application. Some premarket submissions such as PMA (Premarket Approval), De Novo (Evaluation of Automatic Class III Designation) and HDE (Humanitarian Device Exemption) are also required for submission, if applicable. Most of the devices under class II are required to submit 510(K) clearance form whereas, the devices under class III are required to submit PMA approval letter issued by FDA. Once all the clearance is submitted, FDA quality system inspects the manufacturing facilities for its compliance with QSRs. After that, the medical device listing and registration of competent company is done by using FURLS system on the FDA website in accordance with 21 CFR Part 807. The steps for issuing market approval for medical devices in the US are depicted in Figure 1.

 

Figure 1: Steps for medical devices market approval in the US

 

Europe

There is no single body in EU, as in India and USA, to regulate medical devices. However, a decentralized procedure of marketing authorization is followed in EU for regulating medical devices. A third party, i.e. notified bodies, is responsible for issuing Quality Assurance certificates as well as for assuring post-approval compliance to QMS.

European commission has established three directives which are regulated by Medical Devices Directives (MDD) and are allocated to regulate the safety and marketing of medical devices. The three directives are:

  • Medical Device Directive (MDD 93/42/EEC)
  • Active Implantable Medical Device Directive (AIMDD 90/42/EE)
  • In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC)

Classification of medical devices

Europe follows a risk-based classification system which are broadly classified into 3 classes:

  • Class I – Low risk
  • Class IIa – Medium risk
  • Class IIb – Medium/high risk
  • Class III -High risk

Marketing Approval process

The market approval of medical devices in Europe is very different from the regulations in US. First the EU derivative which applies to the medical devices is identified followed by the determination of the class of the medical device according to the Annex IX. For class II and III QMS is implemented for the device in accordance with Annex II or V of the MDD. An authorized representative of Europe is then appointed who can take care of all the regulatory issues. A notified body audits QMS and all the technical documents after which the device registration is done followed by the registration of the competent authority with EU member state. Declaration of Conformity is then prepared which ensures the compliance of medical device with applicable Directive. Finally CE mark certificate for the device is affixed and placed it in market. Additionally, a Conformité Européene or European Conformity (CE) mark certificate is required to commercialize medical devices. The steps required for market approval of medical device in Europe are shown in Figure 2:

 

Figure 2: Steps for medical devices market approval in Europe

 

Canada

The medical devices in Canada are regulated by Health Canada. Therapeutic Product Division (TPD) of health Canada classifies medical devices on the basis of Risk-Based Classification System (RBCS). Health Canada follows a four-class scheme to classify medical devices according to the risk to the human body. Among the four classes, medical devices that possess lowest risk on human body fall under class I while the medical devices with high risk fall under class IV.

Marketing approval in Canada

For issuing market approval of medical device in Canada, first the class of the medical device is determined i.e. from class I to IV in accordance with schedule 1, part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282 as published by Health Canada. Except for class 1 medical devices, implement an ISO 13485:2003 QMS for all the devices followed by audit. Health Canada generally issues two types of licences for market approval of medical devices. These are the Health Canada Medical Device Establishment License (MDEL) and the Health Canada Medical Device License (MDL). MDEL is required for the devices that come under class I while the devices of class II and IV needs to have MDL for the device. Health Canada then reviews Canadian MDL application and Premarket Review Document.The approved application and certificates are posted on the official website of Health Canada and then the device is marketed. The steps for market approval of a medical device in Canada are shown in Figure 3:

 

Figure 3: Steps for medical devices market approval in Canada

 

Turacoz Healthcare Solution (THS) always aims to keep professionals updated about rules and regulations of drugs and devices of different countries. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Report (CER) and Common Technical Documents (CTDs) Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry.

Regulations of Drug Approval in United States, European Union and Canada

Medical Devices,

Introduction

Drug regulations can be defined as the overall control of drug by following rules and regulations which are enforced by the government to protect the health and well-being of humans. They are crucial for ensuring high quality of the drug by confirming its efficacy, safety and quality. Every country has its own regulatory authorities such as the United States Food and Drug Administration (US-FDA for US), the European Medicines Agency (EMA for Europe) and Therapeutic Products Directorate (TPD for Canada which frame the regulatory requirements for development, approval, manufacturing and marketing of the drugs.

Regulations for Drug Approval in United States

USA is the main regulatory agency in the world and hence, it has the strictest standards for approving a new drug in US market. The regulator y authority of US, i.e., USFDA, is responsible for the safety regulation of the food and drug products in US. The drug approval process in US includes filing of Investigational New Drug (IND) application followed by New Drug Application (NDA).

Investigational New Drug Application

Once the drug is found to be safe, as per the reports of the preclinical trails, IND application (IND) is filed to the FDA to start the clinical trials or Phase I trial. The sponsor appointed by the firm or institution is responsible for submitting the IND application to the FDA for which a pre-IND meeting with FDA may be arranged in order to discuss the intended protocol for conducting the trial. The sponsor also provides information related to the chemistry, manufacturing details and quality control of the investigational drug.

New Drug Application (NDA)

After completion of all the clinical trials (i.e. Phase I, II and III trials), if the studies confirm the safety and effectiveness of the investigational drug, the manufacturer can file a New Drug Application (NDA) to the FDA for manufacturing and selling the drug in the US market.

Regulations for Drug Approval in Europe

The regulatory authority of the Europe, i.e., EMA, is responsible for the safety of the public in Europe. Prior to approval for marketing in EU, the applicant has to follow two regulatory steps mentioned below:

  • Clinical trial application
  • Marketing authorization application (MAA)

Clinical Trial Application

In Europe, the drug can be approved by four types of procedures depending upon the drug class and preference of the manufacturer. The four procedures are presented in Figure 1

Figure 1: Drug approval procedures followed in Europe

Marketing Authorization Application

The MAA is an application which is submitted by a drug manufacturer to the EMA in order to seek permission to market a developed drug product in Europe. MAA is approved at both, the state or centralized levels while the clinical trial application is approved at the state level only.

Regulations for Drug Approval in Canada

Therapeutic Products Directorate (TPD) is Health Canada’s federal authority which regulates the drugs and medical devices in Canada for human use. The applicant must present the scientific evidence on the product’s safety, effectiveness, and quality to the directorate in order to obtain permission to sell a drug product.

The Canada’s system of regulating a drug is quite similar to US. If an applicant wants to get marketing authorization in Canada then a new drug submission (NDS) must be compiled with clinical trial information and details of production, packaging, labelling, conditions for use and side effects must be submitted to TPD. Post-submission, it undergoes administrative screening to check the completeness of the document with appropriate format followed by review and assessment of safety, efficacy and quality. The TPD then evaluates the submission and communicates the deficiencies of the NDS to the sponsor to resolve them. After all the issues have been resolved, TPD issues a notice of compliance (NOC).

Turacoz Healthcare Solutions (THS) provides end-to-end regulatory writing support for clinical trials which includes Prescribing Information (PI), Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reposts (CERs) and Common Technical Documents (CTDs).

Regulations of Medical Devices in India: An Update

Medical Devices

Medical devices comprise of a vast range of equipment, ranging from a single pair of tongs to a heart-lung machine. Along with medicines and allied healthcare technologies, medical devices are important for modern patient‑centric care in all sorts of clinical settings like bedside, rural clinics, or metro hospitals. Medical devices have improved the quality of healthcare by making diagnosis, prevention, treatment, and monitoring of diseases simpler and efficient.

Indian medical device industry

Medical device industry is a huge industry, manufacturing wide range of products. In India, the medical device industry has a relatively small share of the global market when it is compared to the size of its economy. India ranks twentieth in the world in medical device market and it is fourth largest market in Asia. Most of the medical devices are imported in India which constitutes over 65% of the total market. The Indian medical device industry is driven by foreign manufacturers. The largest medical device manufacturing segment (53.7%) in India comprises of medical electronics, hospital equipments, and surgical apparatus. Around 31.3% of the medical device industry deals with medical disposables and consumables while diagnostic reagents and implants contributes to 7.9% and 7.1% of the market share respectively (Figure 1).

 

Figure 1*: Components of Indian Medical Devices Industry

*Source: Sethi R, Popli H, Sethi S. Medical Devices Regulation in United States of America, European Union and India: A Comparative Study. Pharm Regul Aff. 2017;6(1):1-9.

Medical devices regulations in India (CLAA scheme)

The Central Drug Standard Control Organization (CDSCO) has assigned a particular division i.e. Medical Device and Diagnostics Division which is dedicated to regulate the medical devices. Under the Central Licensing Approval Authority (CLAA) scheme, the CDSCO notified some of the medical devices and diagnostic kits which are being regulated for the manufacture, import and sale of the medical devices. These medical devices are also called as notified devices. The medical devices are regulated by Drugs and Cosmetics Act (1940) and Rules (1945) for the purpose of import, manufacture, sales and distribution. Currently, fourteen medical devices are notified under the CLAA scheme which are mentioned below:

  1. Disposable Hypodermic Syringes
  2. Disposable Hypodermic Needles
  3. Disposable Perfusion Sets
  4. In-vitro Diagnostic Devices for HIV, HBsAg and HCV
  5. Cardiac Stents
  6. Drug Eluting Stents
  7. Catheters
  8. Intra Ocular Lenses
  9. V. Cannulae
  10. Bone Cement
  11. Heart Valves
  12. Scalp Vein Set
  13. Orthopaedic Implants
  14. Internal Prosthetic Replacements

Current medical device rules (2017) in India

The Government of India has realized the need for framing separate rules and regulations for medical devices in order to improve the Indian regulatory system for medical devices. Hence, Government of India has issued a draft of medical devices to help the medical device industry and will separate the regulatory norms for manufacturing of medical devices from drugs. The draft of medical device was issued on January 31, 2017 and came into force on January 31, 2018.

The new rules and regulations for medical devices will create a novel and different regulatory apparatus by creating a separate registration process for medical devices. The key features of medical device rules, 2017, are summarized below:

  • The new rules have classified the medical devices on the basis of risk. These classes include:
  • Class A – Low risk

(e.g. catheters, surgical dressings)

  • Class B – Low moderate risk

(e.g. disposable hypodermic needles, orthopedic implants)

  • Class C – Moderate high risk

(e.g. cardiac stents, internal prosthetics replacements)

  • Class D – High risk

(e.g. drug eluting stents, heart valves)

  • The Indian regulators will have unique identification for their devices.
  • The medical devices should follow the standards established by the Bureau of Indian Standards (BIS). Where no relevant standard of any medical device has been laid down, then those devices should follow the standards laid down by International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards.
  • Licenses will remain valid indefinitely which are issued to the device registrants, along with the payment of the license retention fees, unless cancelled or surrendered.
  • Licenses and registration certificates received before the implementation of the new rules will be valid till expiry or after an 18-month period following implementation, whichever is later.
  • Test license will be valid only for one year.
  • The manufacturing sites of the devices will be audited by the notified bodies.
  • Medical devices for which trials are not required will need only a pilot study on a smaller population in order to test the safety and performance of the device followed by a pivotal trial on a large population.
  • These rules would be imposed by Central Licensing Authority and State Licensing Authority
  • The Central Licensing Authority is responsible for importing medical devices of all classes, and manufacturing of class C and D medical devices. Also, it is responsible for clinical investigation and approval of investigation of devices, and co-ordination with the State Licensing Authorities.
  • The State Licensing Authorities are responsible for the manufacturing, sale, and distribution of the devices that fall under class A or B, and also, control of sale, stock, exhibit, or offer for sale or distribution of in-vitro medical devices (IVDs) of all classes.

The new rules for medical devices will improve the accessibility and affordability of medical devices globally and will create a favourable and encouraging environment for development and innovation of new medical devices in India. The main objective of Government of India, through these rules, is to develop the confidence of the investors in medical device industry in India and to maintain the quality of all devices as per the international standards.

Turacoz Healthcare Solutions (THS) always aims to keep professionals updated on the current rules and regulations pertinent to regulatory affairs. Turacoz is dedicated towards providing scientific/medical writing support to the industry and academia. With expertise in various clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Document (CTD), and Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry.

Clinical Evaluation Report for Medical Devices-Role of Medical Writer

Medical Devices

Clinical Evaluation Report for Medical Devices

Clinical evaluation report (CER) is a document containing information regarding clinical evaluation of a medical device. CER is intended to be reviewed by the Notified Body (NB). Clinical evaluation refers to an organized procedure (Figure 1) used to collate, compile, and analyze clinical data related to a medical device. The clinical data includes updated published information on a medical condition and the medical device which is obtained from various databases. It also includes pre-clinical and clinical data, quality control data, and risk management and post-market surveillance related inputs which are obtained from manufacturers, quality and safety scientists, respectively. The clinical information also includes the instructions to be followed while using the medical device. The CER is prepared as per the guidelines mentioned in MEDDEV 2.7/1 Rev. 4 (June 2016). It specifies the structure as well as content to be added in the CER.

 

Figure 1: Organized procedure followed for Clinical Evaluation of a Medical Device

(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)

 

MEDDEV 2.7/1 Rev. 4 (June 2016)

MEDDEV 2.7/1 Rev. 4 (June 2016) is the guideline followed to prepare the CER. It includes summary of CER, updated published information about medical condition for which the medical device is used, as well as complete information about device under evaluation (Figure 2).

Figure 2: Table of content for development of Clinical Evaluation Report

(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)

Role of Medical Writer in the Development of Clinical Evaluation Reports

Medical writer plays an essential role in development of CERs. According to the requirements of MEDDEV 2.7/1 Rev. 4 (June 2016), the medical writer performs various activities (Figure 3).

Figure 3: Role of a medical Writer in development of Clinical Evaluation Report

Turacoz Healthcare Solutions, a medical communication company, provides latest updates on medical devices. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs), Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the Pharma and different sectors of Healthcare Industry.