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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
      • Templates
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-008 Product requirements

GP-008 Product requirements

Purpose​

To describe the process to establish the methodology to achieve and maintain compliance with the European and state regulatory requirements for the medical devices we develop.

Scope​

All the medical devices we develop and place on the market.

Definitions​

  • Intended purpose: the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
  • Unique Device Identifier (UDI): a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
  • Making available on the market: any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
  • Putting into service: the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
  • Manufacturer: a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
  • AEMPS: Agencia Española de Medicamentos y Productos Sanitarios.

Responsibilities​

JD-005​

To accomplish legal compliance and all the regulatory requirements of the medical devices.

JD-004​

To ensure all the documents and records that guarantee the medical devices regulatory requirements compliance are performed according to our GP-001 Documents and records control.

JD-003​

To review the GSPR, organize and manage development resources to achieve compliance with requirements.

JD-001​

To approve the procedure and provide with the required resources to perform the activities described on it.

Inputs​

  • Applicable legal requirements (MDD 93/42/EEC, MDR 2017/745, Royal Decree (RD) 192/2023)

Outputs​

  • Technical files in accordance with all the applicable requirements of the legislation
  • Applicable regulatory certification (CE certification)
  • Placing on the market our products in accordance with all the applicable legal requirements
  • Spanish manufacturer license for medical devices managed by the AEMPS
  • T-008-001_GSPR
  • T-002-008_Quality and regulatory roadmap

Development​

In order to place medical devices into a specific market, we analyze the regulatory and legal requirements (country-specific) applicable to our device early in the development stage of the device (design planning). This includes providing the device with a classification according to the risk and intended use associated with it and following the regulatory path related to the chosen classification. The process of identifying and analyzing the applicable regulatory and legal requirements is performed for every market where we aim to place our device and it is mainly done by JD-004. Sometimes external consultants are also involved in the definition of regulatory requirements to enter in a new market. Identification of new and/or revised applicable regulatory requirements is also performed very 6 months (the outcomes are documented in the T-002-009 Regulatory requirements review report) and as part of the activities of the annual management review documented in the T-002-004 form.

One of the outputs of this analysis is the regulatory roadmap: it is a document that provides a plan with milestones for obtaining medical device approval in selected countries (according to the strategy of Legit.Health), documented in T-002-008 and reviewed on a quarterly basis.

For the European market, MDR 2017/745 is the regulation to follow to understand the requirements, and the appropriate conformity route is chosen in accordance with Article 19 of MDR 2017/745 (EU declaration of conformity). A Notified Body shall be appointed (have a contract in place) to be able to certify the conformity of our device. This assessment is composed by technical file revision and audit execution according to the requirements of ISO 13485 and MDR 2017/745 (see section below for more details) .

Among other MDR requirements, the following have been identified prior the compilation and submission of the technical file:

  • PPRC designation according to article 15 of MDR 2017/745 (the responsibilities of the PRRC are detailed in the applicable job descriptions (JD-004 and JD-005))
  • GMDN code assignation
  • Device's classification according to Annex VIII of MDR 2017/745
  • Route of conformity according to the device's classification. More details about the determination of the device's classification and the route of conformity are provided in the technical file of the device.

Another target market for our device is the US market: the applicable regulatory requirements are under evaluation in order to classify the device based on its associated risk, intended use and availability of predicate device. Once the classification is determined and applicable regulatory requirements identified, we will create a procedure to collect and describe all the US requirements to place a medical device in the market and we will create compliant technical documentation.

The following sections provide more details about the device’s technical file and other applicable requirements to be able to place medical devices into the European market, also considering local (Spanish) requirements.

Essential regulatory requirements​

We have competent personnel and sufficient resources to ensure that the medical devices are designed and developed in a way that they meet the General Safety and Performance Requirements (GSPR) of Annex I of MDR 2017/745. The PRRC (JD-004 and JD-005) assures that this compliance can be demonstrated with the checklist of the GSPR of the Technical File of each one of the products (T-008-001_GSPR) as well as with the documents referenced in the checklist.

For the conformity evaluation of each product, an appropriate conformity route will be chosen in accordance with Article 19 of MDR 2017/745 (EU declaration of conformity), in collaboration with the Notified Body (if it is necessary by the product type).

The main data related to the essential regulatory requirements are included in the corresponding Technical File:

  • Product description and specifications
  • Label & information provided by manufacturer
  • Design, redesign and manufacturing
  • General safety and performance requirements checklist (T-008-001_GSPR).
  • Benefit risk analysis & risk management
  • Product verification and validation
  • Post-market surveillance
  • Declaration of conformity
  • Technical details

In case of class I medical device certified under MDD 93/42/EEC, we ensure its compliance with the applicable Essential Requirements set out in Annex I of MDD 93/42/EEC.

Management of Technical File of the medical devices​

For each medical device we develop, we establish and maintain a Technical File which is the file that contains the specifications of a finished product (description, specifications, protocols, verifications and validations) and the requirements of the quality management system and the complete manufacturing process (procedures, instructions and guidelines).

In addition, each product must have:

  • Declaration of conformity. In the Annex IV of MDR 2017/745, the regulatory requirement to issue and maintain the declaration of conformity of the medical device is established, where the manufacturer guarantees that the product accomplishes the general requirements and the applicable regulation.
  • Certificate of conformity (for class IIa, IIb and III products).
  • Communication of first marketing or putting on the market for class IIa, IIb and III medical device by each actor who markets the product on the Union market.
  • Registration of the person responsible for placing medical devices on the market for class I medical devices, custom products, grouping of medical devices, natural or legal person that sterilizes products for their putting on the market and established authorized representatives in Spain, when applicable.
  • Registration of the Person Responsible for Regulatory Compliance (PRRC).

Applicable legislation requirements of Royal Decree (RD) 192/2023​

The Royal Decree 192/2023 establishes requirements for manufacturer who develop, manufacture and place medical devices into the spanish market.

According to article 7, prior to place a medical device in the market, the manufacturer shall request to AEMPS and obtain the manufacturing license (the request shall be managed in the following AEMPS webpage: https://fabricaps.aemps.es/fabricps/faces/login.xhtml). The required documentation to submit to AEMPS for obtaining the license is specified in article 8 of the royal decree and, among the requirements, there is the appointment of a technical manager.

The manufacturing license has a validity of 5 years, therefore manufacturer shall request to AEMPS the renewal of the license before its expiration.

In case of any changes in the information provided in the manufacturing license (e.g. change in technical manager, change in the scope of the license), the manufacturer shall notify AEMPS about the changes prior to their implementation and wait for AEMPS approval. The manufacturing license's changes are managed according to the process established in GP-023 Change control management.

Once the medical device is compliant with the applicable regulation (MDD 93/42/EEC for the class I legacy device, MDR 2017/745 for class IIa device) and has obtained the required medical device approval (if applicable), the manufacturer shall register the medical device into the AEMPS medical device registry, according to article 18 of the royal decree. The medical device registry shall be updated by the manufacturer every time there is a change in the submitted information (e.g. labeling of the device, change in the name of the device).

According to the Disposición transitoria séptima. Registro de comercialización. of the royal decree, until the AEMPS medical device registry is fully available, the manufacturer shall register the medical device according to the previous royal decree 1591/2009 (article 22, 23, 24).

According to these articles, class I medical devices shall be registered through the telematic application RPS (AEMPS application: https://sede.aemps.gob.es/PSCH/PS/rrps.html). Then, the product registration will be renewed yearly.

Class IIa, IIb and III medical devices shall be registered through the telematic application CCPS (AEMPS application: https://sede.aemps.gob.es/PSCH/PS/ccps.html).

The manufacturer shall register the medical devices in the applicable AEMPS application no later than 6 months after the registration of the same medical device in Eudamed.

According to Disposición transitoria octava, the legacy device certified under MDD 93/42/EEC shall comply with the requirements set out in the royal decree 1591/2009 with the exception of the articles listed in Disposición derogatoria única. Derogación normativa.

Medical Device technical documentation​

The Technical Documentation of the medical device contains, at least:

Device description and specification​

  • Product name and a general description of the device including its lifetime, intended environment, intended purpose and intended users.
  • Basic UDI-DI assigned by the manufacturer
  • The targeted patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria (inclusion/exclusion), indications, contra-indications and warnings.
  • Principle of operation of the device
  • Rationale for the qualification of the product as a medical device.
  • The risk class of the device and the justification for the classification rules applied in accordance with Annex VIII of MDR 2017/745.
  • The conformity assessment route.
  • Explanation of any novel features.
  • Description of the device accessories, and other products which are intended to be used in combination with it.
  • Description of any consumables associated with the device.
  • Description of the different configurations/variants of the device.
  • General description of the main functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams.
  • Characterization of the raw materials.
  • Technical specifications, such as features, dimensions and performance attributes of the device.
  • Product history including previous generations, novel features and other similar devices on the market.

A minimum retention period of 10 years is defined, since the last date of commercialization of the last product, during which at least one copy of the obsolete documents of the Technical File of the product is retained.

This period ensures that the documents belonging to the medical devices that have been manufactured and tested are available for at least the lifetime of the medical device. This duration is in no case less than the retention period of any resulting record or as specified by the pertinent regulatory requirements.

Information to be supplied by us as the manufacturer​

  • Label placed on the product and on its packaging in the languages in which the product is intended to be sold.
  • Instructions for use in the languages where the device is envisaged to be sold.
  • Quality seal, bar code and UDI, if applicable.

Design and manufacturing information​

  • Information to allow the design stages applied to the device to be understood.
  • Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the Technical Documentation.
  • Identification of all the sites, including those from suppliers and sub-contractors when applicable, where design and manufacturing activities are performed.

General safety and performance requirements (GSPR)​

The demonstration of conformity of the GSPR will be detailed at the T-008-001_GSPR and it will include:

  • The GSPR that apply to the device and an explanation as to why others do not apply.
  • The methods used to demonstrate conformity with each applicable GSPR.
  • The harmonized standards, other standards and common specifications.
  • The precise identity of the controlled documents offering evidence of conformity with each harmonized standard, common specifications or other method applied to demonstrate conformity with the GSPR. There shall be incorporated a cross-reference to the location of such evidence within the full Technical Documentation and, if applicable, in the summary of the Technical Documentation.

Benefit-risk analysis and risk management​

The risk management is performed according to Procedure GP-013 Risk management, and the Technical Documentation includes information about:

  • The risk management plan.
  • The risk acceptability including the benefit/risk analysis.
  • The risk management team.
  • The solutions adopted and the results of risk management.
  • The complaint history.
  • The procedure for reviewing the risk management.
  • The risk management report.

Product verification and validation​

  • Tests results and evaluation of the bibliography.
  • Detailed information on trial design, protocol, data analysis methods, and data summary and conclusions.
  • Product verification and validation.
  • The T-015-001 Clinical evaluation plan and the T-015-003 Clinical evaluation report and its updates.
  • The T-007-001 Post-market surveillance plan, the T-007-002 Post-market clinical follow-up plan and the evaluation reports of said monitoring.
  • The GSPR compliance.

Clinical evaluation​

We perform and document a clinical evaluation to confirm compliance with the GSPR, as well as to evaluate undesirable side effects and the acceptability of the benefit-risk ratio, according to the Procedure GP-015 Clinical evaluation.

EUDAMED​

The European Commission maintains a database (EUDAMED) with the aim of making it possible for the public to be adequately informed about the products placed on the market, allow the unique UDI identification of the products and facilitate their traceability, inform about the clinical investigations, and allow manufacturers to meet surveillance obligations.

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en

The EUDAMED database will have 6 modules, of which the following are currently active:

EUDAMED - Actor Registration​

We carry out the management in the EUDAMED database, through the actor registration module, to obtain the SRN, the unique identification number for manufacturers of medical devices. Our SRN can be consulted at the EUDAMED actor identification document within the Licenses and accreditations folder.

https://ec.europa.eu/health/md_eudamed/actors_registration_en

EUDAMED - UDI/Device Registration​

As a manufacturer, we send the UDI / devices information of all the products we place on the EU market EUDAMED, through the EUDAMED UDI / Devices registration module. The EU product identification system based on a Unique Device Identifier (UDI), allows easier traceability of medical devices.

Manufacturers can now enter information on a voluntary basis. The mandatory use of the system will start when the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations.

https://webgate.ec.europa.eu/eudamed/landing-page#/

EUDAMED - Notified Bodies and Certificates​

The Notified Bodies and Certificates module establishes that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. Such information is accessible to the public.

https://webgate.ec.europa.eu/eudamed/landing-page#/

Associated documents​

  • T-002-008_Quality and regulatory roadmap
  • T-002-009 Regulatory requirements review report
  • T-007-001 PMS plan
  • T-007-002 PMCF plan
  • T-007-003 PSUR
  • T-007-004 PMS evaluation report
  • T-007-005 PMCF evaluation report
  • T-008-001_GSPR
  • T-015-001 CEP
  • T-015-003 CER
  • GP-001 Control of documents
  • GP-007 Post-market surveillance
  • GP-013 Risk management
  • GP-015 Clinical evaluation
  • GP-023 Change control management

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-003, JD-004
  • Reviewer: JD-005
  • Approver: JD-001
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Templates
  • Purpose
  • Scope
  • Definitions
  • Responsibilities
    • JD-005
    • JD-004
    • JD-003
    • JD-001
  • Inputs
  • Outputs
  • Development
    • Essential regulatory requirements
    • Management of Technical File of the medical devices
    • Applicable legislation requirements of Royal Decree (RD) 192/2023
    • Medical Device technical documentation
      • Device description and specification
      • Information to be supplied by us as the manufacturer
      • Design and manufacturing information
      • General safety and performance requirements (GSPR)
      • Benefit-risk analysis and risk management
      • Product verification and validation
    • Clinical evaluation
    • EUDAMED
      • EUDAMED - Actor Registration
      • EUDAMED - UDI/Device Registration
      • EUDAMED - Notified Bodies and Certificates
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)