MDR TECHNICAL DOCUMENTATION

The role of Notified Bodies in assisting manufacturers in delivering only safe and compliant medical products to the EU market is critical. The function of the notified body is to audit the manufacturer’s quality management system and examine the Technical Documentation of devices in classes I, II, and III. Notified bodies will issue CE Certificates, MDR Technical Documentation Assessment Certificates, or Type Examination Certificates, depending on the device’s class. Manufacturers can look up a list of Notified Bodies on the European Commission’s website. Your Notified Body shall, according to Annex VII of the EU MDR:

  • Assess your technical documentation based on its predefined sampling plan.

  • Assess your product technical documentation safety and performance requirements: Annex I.

  • Take into account requirements related to preclinical testing and clinical evaluations.

  • Ensure that technical documentation findings are appropriately and consistently classified based on a procedure to assess compliance with requirements of the EU MDR and relevant standards.

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TECHNICAL DOCUMENTATION FOR MEDICAL DEVICE

Manufacturers are required by law to demonstrate that they are in compliance with MDR standards. The EU Medical Device Regulation (MDR) uses technical documentation (sometimes known as a “technical file”) to establish that a medical device fulfils the general safety and performance standards.
The MDR defines which components in technical file must be included:

This section is providing an overview of your device. The viewer should be able to understand what your product looks like, what it is made of, how large it is, how many variants there are, whether it requires any accessories, what it’s intended usage, and who the product’s users are. It’s also important to explain how the product works, whether there are any warnings or precautions to take when using it, and when it can’t be used (contraindications). Also important to explain how the product is classed, including which Annex 8 rules apply and how the product is classified (Article 51).

Device information, label and instructions of use (IFU)

Documents related to device development and describe manufacturing process

ISO 14971: 2019 contains guidelines for risk management. Application of risk management to medical device

Clinical evaluation of  medical devices must follow MDR Article 61 and must be following guidance document MEDDEV 2.7.1 Rev 4

This section covers all tests which prove your product safety and performance such as: safety regarding chemical component, biocompatibility test, stability, any other test which proves performance of the device, Clinical investigation Etc.

  1. Post market surveillance plan
  2. Post market surveillance report or Periodic safety update report

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TECHNICAL FILE FOR IN VITRO DIAGNOSTIC DEVICES (IVDS)

The IVDR Technical Documentation, as well as its summary, must be given in a clear, organized, searchable, and unambiguous way, and must include the components mentioned in Annex II and III of the IVDR.

Device Name, common name and GMDN code

Device Intended use

Risk Class

Device specification, principles of method/operation, etc

Overview of previous and similar generations of the device with respect to state of Art

Design and Development (Formulation)

Manufacturing information

EN ISO 14971:2020 is the latest updated standard

As the IVD developer, you must show that your test is required to make a medical judgement based on the device’s approved indications for use.

  • Scientific validity report
  • Analytical performance report
  • Clinical performance report

Clinical Performance Validation has to demonstrated via:

  • Clinical performance studies
  • Peer-reviewed published literature
  • Experience gained through routine testing

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ABOUT  GSPR

The GSPR is known as General Safety and Performance Requirements are listed in Annex I of EU MDR 2017/745. The goal of the GSPR to provide evidence that device design and manufactured in accordance with all applicable requirements in order to ensure device safety and performance.

GSPR has 23 requirements under MDR. Manufacturers must fulfill these requirements and provide sufficient evidence, such as conformity evidence, to demonstrate that they have fulfilled the GSPR.

In practice, GSPR compliance is usually performed by using a checklist or table framework to ensure for applicability, justification (if not applicable), and method or standard that corresponds to a specific need. When a requirement applies, it must be answered with a simple “YES.” You can also specify the method and harmonized or state-of-the-art standard that you used to demonstrate conformity with specific standards. When a requirement is not applicable, a statement in the applicable column must be made as “NA” or “NO.” In order for a third party to understand reason, it must also provide clear justification for why the requirement is not applicable.

In Annex I of the EU IVDR, the GSPRs are listed. The bulk of the standards, like GSPR 1, are founded on principles, guaranteeing that when the state of the art evolves, a manufacturer evaluates whether the IVD stays compliant.

The GSPRs are divided into three groups:

Chapter 1: GSPRs 1 to 8 in Annex I are general requirements. All IVDs are subject to these GSPRs.

Chapter 2: GSPRs 10 to 19 are performance, design, and manufacturing requirements, and each GSPR must be evaluated for its application.

Chapter 3: Requirements for Information Provided The last chapter of this Annex, With the Device, is devoted to one overarching criterion that applies to labels and instructions for usage. There are several sub-requirements inside this single GSPR. The majority of IVD will apply.

RISK ANALYSIS AND IMPORTANCE OF IT IN MDR IMPLEMENTATION

The systematic process of identifying, analyzing, reducing, eliminating, and drawing conclusions from medical risks related to the use of a medical device is known as medical device risk management.

Risk is a requirement that extends through all elements of the MDR technical documentation. Each of the documentation listed so far has been developed from a risk perspective in order to demonstrate that it must be done the necessary steps and measures to reduce the risks. ISO 14971: 2019 Medical devices – Application of risk management to medical devices contains risk management guidelines. In addition, the requirements stated in Chapter 1 of the GSPR must be taken into consideration.

To begin, a risk management procedure must be established. Then, over the duration of the product’s life cycle, you must undertake a risk assessment (from design, entry of raw materials into the warehouse, through the production itself to the use of the product by the patient or user and disposal). The next stage is to implement a variety of strategies to reduce and maintain these risks.

PRODUCT VERIFICATION AND VALIDATION IN MDR CE MARKING

While doing a design and development Verification and the validation process is important. Design verification is carried out according to the planned and documented arrangements to ensure that the design and development outputs meet the design and development input requirements. Validation is performed in accordance with the planned & documented arrangements to ensure that the resulting product is capable of meeting the requirements for the intended use.

In this section of verification and validation covers all test done on device to prove its safety and performance, such as: Biocompatibility, safety regarding chemical components, electrical safety, stability, when stored under prescribed condition, sterility, any other test that prove performance of the device, clinical investigation etc.  The protocols or plans, as well as the results of these tests, are the documentation for these pre-clinical data that must be attached. Clinical data, which can be obtained by clinical evaluation or clinical investigation, is important in addition to pre-clinical data. A clinical evaluation is used to evaluate and analyze clinical data relating to a medical device in order to provide evidence of the product’s clinical safety and performance.

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