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TECHNICAL FILE FOR CE MARKING MEDICAL DEVICES/ ACCESSORIES ACCORDING TO EU MDR 2017/745 Document Number: TF001
CONFIDENTIAL CE TECHNICAL FILE Title All correspondence concerning this technical file should be directed to:
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The contents of this file are highly confidential and should not be disclosed to any third party without the prior approval of the manufacturer. PREPARED BY: PRINT NAME Adnan Ashfaq
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TECHNICAL FILE FOR CE MARKING MEDICAL DEVICES/ ACCESSORIES ACCORDING TO EU MDR 2017/745
TF001
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Contents 1.
ADMINISTRATIVE INFORMATION ........................................... Error! Bookmark not defined. 1.1
Part I. List of Terms and Acronyms .......................................... Error! Bookmark not defined.
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Part II. Identification of the Manufacturer & contact person .. Error! Bookmark not defined.
1.3 Part III. European Economic Area Authorized Representative & ImporterError! Bookmark not defined. 1.4
Part IV. Product Identification & Classification ........................ Error! Bookmark not defined.
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Part V. Conformity Assessment Route ..................................... Error! Bookmark not defined.
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Part VI Identification of Notified Body ..................................... Error! Bookmark not defined.
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Part VII Declaration of Conformity ........................................... Error! Bookmark not defined.
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Part VIII Use of Harmonised Standards .................................... Error! Bookmark not defined.
2. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES ..................................................................................... Error! Bookmark not defined. 2.1
Device description and specification ....................................... Error! Bookmark not defined.
Product Code ....................................................................................... Error! Bookmark not defined. Description............................................................................................ Error! Bookmark not defined. Product Code ....................................................................................... Error! Bookmark not defined. Description............................................................................................ Error! Bookmark not defined. 2.2
Device Specification ................................................................. Error! Bookmark not defined.
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Reference to previous and similar generations of the device . Error! Bookmark not defined.
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INFORMATION TO BE SUPPLIED BY THE MANUFACTURERError! Bookmark not defined.
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DESIGN AND MANUFACTURING INFORMATION ................ Error! Bookmark not defined.
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GENERAL SAFETY AND PERFORMANCE REQUIREMENTSError! Bookmark not defined.
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BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT ........ Error! Bookmark not defined.
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PRODUCT VERIFICATION AND VALIDATION....................... Error! Bookmark not defined. 7.1
Stability:.................................................................................... Error! Bookmark not defined.
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Journey Hazard Testing ............................................................ Error! Bookmark not defined.
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Pre-clinical and clinical data ..................................................... Error! Bookmark not defined.
7.4 Production Verification and Validation; Software Verification and ValidationError! Bookmark not defined. 7.5
Shelf Life ................................................................................... Error! Bookmark not defined.
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Production Verification and Validation; Biological Safety ....... Error! Bookmark not defined.
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Production Verification and Validation; Animal Studies .......... Error! Bookmark not defined.
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Production Verification and validation; Sterilisation ............... Error! Bookmark not defined.
8. TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCEError! Bookmark not defined. 8.1 The post-market surveillance plan drawn up in accordance with Article 84.Error! Bookmark not defined. 9.
Checklist GSPRs ........................................................................... Error! Bookmark not defined. Appendix 1 - Declarations of Conformity ............................................. Error! Bookmark not defined. 10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.Error! Bookmark not defined. Appendix 2 – General Safety and Performance Requirements ChecklistError! Bookmark not defined. Appendix 3 - Risk Analysis documents ................................................. Error! Bookmark not defined. Appendix 4 – Sterilisation Validation -Reports .................................... Error! Bookmark not defined. Appendix 5 - Clinical Evaluation Report ............................................... Error! Bookmark not defined.
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Post Market Clinical Follow - UP (PMCF) (Your company logo)
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Table of Contents 1.0
Introduction..................................................................................... 3
2.0
Key Objectives ............................................................................... 3
3.0
Responsibilities .............................................................................. 3
4.0
Procedure ....................................................................................... 4
4.1 PMCF Plan ..................................................................................... 4 4.2 PMCF Review ................................................................................. 6 4.3 PMCF Report .................................................................................. 7 Appendix: Explanation of PMCF under the EU MDR 745/2017 .............. 8
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1.0 Introduction PMCF is a continuous process to update the clinical evaluation and address the post market surveillance plan. It's the manufacturer's obligation to collect and evaluate the clinical data from the use of the device. The aim of the assessment procedure is to ensure the safety and the performance of the device and identify any emergency risk. The purpose of this document is to define the Post Market Surveillance (PMS) activities of the product XXXX. The range of products is listed below (if necessary). Range
of
Product
(add
and
remove XXXX
XXXX
columns ) Medical Device Family/Category Device Name(s) Add any relevant information about the product such as device identifier etc.
Device Description At this section give a brief summary of the function of the device (usage of the device), a summary of the warnings, the identification of product labelling, principles of operations etc. and attach the design specification in Appendances. 2.0 Key Objectives This document is aiming to establish the requirements of the PMCF including the PMCF plan, report and review of the product XXXX. 3.0 Responsibilities The manufacturer of the device XXX shall proactively collect and evaluate the clinical data from the users of the device XXXX.
Guidance Document Post Market Surveillance (PMS) Periodic Safety Update Report (PSUR) Post Market Clinical Follow-up (PMCF)
Table of Contents 1.0
Introduction .................................................................................................................. 3
2.0 Scope and Objective ............................................................................................................. 3 3.0 Relationship between PMS/PSUR/PMCF .............................................................................. 3 4.0 PMS/PSUR/PMCF under EU MDR ......................................................................................... 3 5.0 PMS/PMCF/PSUR under MDD .............................................................................................. 3 6.0 Conclusion ......................................................................................................................... 11
Appendix A: Explanation of PMS/PSUR/PMCF under the EU MDR 745/2017 .................... 12
1.0 Introduction The Post-market surveillance (PMS) was a process which already existed in the EU MDD in Annex X but it was not clearly defined through the EU MDD. On the other hand, the new regulation EU MDR has clearly defined the PMS which also includes the Post Periodic Safety Update Report (PSUR) and Post Market Clinical Follow Up (PMCF), as agreed with the European Parliament and Council in May 2017. The new EU MDR is valid from the 26th of May 2020 and till this date; the medical devices must meet the new requirements of EU MDR. The EU MDD is now expanded to EU MDR, although many parts have changed, renamed or added. In the EU MDR the post-market surveillance, changed and became more complicated which is expand in the Articles 83, 84, 85. In addition, descriptions of PSUR and PMCF are found in Article 86 and Annex XIV respectively, of the EU MDR.
2.0 Scope and Objective This report is aiming to give guidance to the manufacturers, how to respond to their responsibilities and develop a post-market surveillance report and meanwhile meet the requirements of EU MDR. The purpose of this report is to collect all the information from 2017/745 EU MDR about post-market surveillance, post periodic safety update report and post market clinical follow up and explain their requirements. In addition, where it is applicable the EU MDR is compared with MDD.
3.0 Relationship between PMS/PSUR/PMCF PMS is a procedure referred to the manufacturer of medical devices and is an essential process in order for the product to become available on the market. PMS is a systematic procedure of the post phase of the production where the manufacturer review and evaluate the experience gained from the device. The manufacturer is responsible to carry out any appropriate corrective action after evaluation of the experience. The systematic procedure is document and be always up to date. The PMS is part of the Quality Management System (QMS) and includes further procedures such as Post Market Clinical Follow Up (PMCF) which is already introduced in EU MDD and expanded in EU MDR. Also, the EU MDR introduce the Periodic Safety Update Report (PSUR) which is a summary of the results and the analysis of the PMS data. Diagram 1 represents the subdivisions of the QMS in regard to PMS and show the key requirements of PMS procedures.
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Post Market Surveillance (PMS) & Periodic Safety Update Report (PSUR) (Your company logo)
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Table of Contents 1.0
Introduction .................................................................................................................. 3
2.0
Key Objectives ............................................................................................................. 4
3.0
Responsibilities ............................................................................................................ 4
4.0 Procedure .......................................................................................................................... 4 4.1 PMS Plan ....................................................................................................................... 5 4.2 PMS Review ................................................................................................................... 8 4.3 PMS Report .................................................................................................................... 8 4.4 PSUR ............................................................................................................................. 8 Appendix: Explanation of PMS/PSUR under the EU MDR 745/2017 .................................... 10
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1.0 Introduction PMS is a procedure referred to the manufacturer of medical devices and is an essential process for the product to become available on the market. PMS is a systematic procedure of the post phase of the production where the manufacturer review and evaluate the experience gained from the device. The manufacturer is responsible to carry out any appropriate corrective action after evaluation of the experience. The systematic procedure is document and be always up to date. The post-market surveillance according to the 2017/745 EU MDR must include urgent and non-urgent incidents and Periodic Safety Update Reports (PSUR) for only class IIa, IIb and III devices. The purpose of this document is to define the Post Market Surveillance (PMS) activities of the product XXXX. The range of products is listed below (if necessary). Range
of
Product
(add
and
remove XXXX
XXXX
columns) Medical Device Family/Category Device Name(s) Add any relevant information about the product such as device identifier etc. Device Description At this section give a brief summary of the function of the device (usage of the device), a summary of the warnings, the identification of product labelling, principles of operations etc. and attach the design specification in Appendances.
Unique Device Identifier (UDI) Guidance Document
Table of Contents 1.0 Introduction .................................................................................................................................... 3 2.0 Key Objectives .............................................................................................................................. 3 3.0 Responsibilities ............................................................................................................................. 3 4.0 Definitions ...................................................................................................................................... 4 5.0 General requirements of the UDI ............................................................................................... 5 6.0 Specific requirements of the UDI ............................................................................................... 6 7.0 European database on medical devices (EUDAMED)............................................................ 7 8.0 UDI Database................................................................................................................................ 8 9.0 Specific Rules ............................................................................................................................. 10 Appendix: References from 2017/745 EU MDR ........................................................................... 11
1.0 Introduction Unique Device Identifier (UDI) is defined in a series of characters which is created in order to identify a device. The new regulation EU MDR 2017/745 introduces the UDI system which is similar to the Global Regulatory Data Standards. It is hard to achieve a single worldwide UDI database although, in the near future several regional regulators will adopt UDI standards. The UDI system is aiming to improve the safety and accurate the reporting. Also, its purpose is to monitor the corrective actions and have more efficient IDs (fewer counterfeits). According to EU MDR 745/2017, only if the device is assigned to the UDI system can be released on the market. It is the manufacturer's obligation to assign the device in the UDI system and comply with the essential requirements. The aim of this guidance is to illustrate the manufacturer to the UDI system and define its obligations in regard to the UDI system. The UDI system includes the UDI database which part of the EUDAMED (European database on medical devices) and is illustrated in this document.
Economic Operators Guidance Document
Table of Contents 1.0 Introduction ......................................................................................................................... 3 2.0 Scope and Objective ............................................................................................................. 3 3.0 Economic Operators under EU MDR ..................................................................................... 4
Identification within the supply chain ........................................................................................................... 7
4.0 Economic Operators under EU MDD ..................................................................................... 7 5.0 Comparison of economic operators under EU MDD and EU MDR (where possible)............... 9
Manufacturer ............................................................................................................................................... 9 Authorised representative ........................................................................................................................... 9 Importer ....................................................................................................................................................... 9
Appendix A: Explanation of economic operators under the EU MDR 745/2017 ........................ 10
1.0 Introduction Economic Operators have recently adopted by the new regulation EU MDR 745/2017, as agreed with the European Parliament and Council in May 2017. The new EU MDR is valid from the 26th of May 2020 and till this date, the medical devices must meet the new requirements of EU MDR. The EU MDD is now expanded to EU MDR, although many parts have changed, renamed or added. The EU MDR state that economic operators are the manufacturer, the authorised representative, the importer and the distributor and each of them have different responsibilities which are listed in the Articles 10,11,13,14 respectively. On the other hand, in the EU MDD, the economic operators are suggested to be the manufacturer which is welldefined, the authorised representative, the distributor and the suppliers which are referred through the regulation.
2.0 Scope and Objective This report is aiming to give guidance to the manufacturers, how to respond to their responsibilities and provide the authorised representatives, importers and distributors with their responsibilities in order to meet the requirements of EU MDR. The aim of this report is to collect all the information from EU MDR 2017/745 about the economic operators and give a description of the new requirements. In addition, where it is applicable the EU MDR is compared with EU MDD.
Guidance for EU MDR - Software as a Medical Device (SaMD)
Contents
1.0 Introduction ............................................................................................................................................ 2 2.0 Scope and Objective................................................................................................................................ 2 3.0 What is Software under the MDD? ......................................................................................................... 2 4.0 What is Software under the EU MDR? .................................................................................................... 3 5.0 A deeper look at Rules 11, 17 and 22 ..................................................................................................... 8 Software that will be classified higher from the MDD to the EU MDR ............................................... 11 6.0 Regulatory pathway for SaMD .............................................................................................................. 13 7.0 Examples of Software under the EU MDR ............................................................................................ 14 Appendices:................................................................................................................................................. 20 Appendix A: EU MDR vs MDD Comparison Table ....................................................................................... 21
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Guidance for EU MDR - Software as a Medical Device (SaMD)
1.0 Introduction Software has developed considerably since the Council Directive 93/42/EEC (EU MDD) which was released in 1993. Manufacturers of such digital health technologies, medical applications and wearable body sensors as examples, must carefully consider the new rules and regulatory requirements set forth within the EU Medical Devices Regulation 2017/745 (EU MDR), adopted by the European Parliament and Council in May 2017. The new EU MDR, with a mandatory compliance date of 26 May 2020, replaces the former MDD, and introduces new concepts, definitions, classification rules and procedural requirements for medical device software – and particularly for software products regulated as Class I medical devices in Europe. Many digital health technologies will now fall into the scope of the new EU MDR.
2.0 Scope and Objective The aim of this document is to provide guidance regarding classification and regulatory compliance of software intended to be used as a medical device in accordance with directives and regulations in the medical device regulation 2017/745 (EU MDR). Under the MDD previously there were 18 rules for active devices and now under the EU MDR there are 22 rules. The scope of this document is to help those needing to classify their device under one of the rules of the EU MDR quite clearly with less need for ambiguity.
3.0 What is Software under the MDD? Under the MDD there were 18 rules in total and the software section was not clearly identified. The rules for software were mainly under the active devices section (as per Med Dev 2.4.1 Rev 9 Classification of Medical Devices), Rule 9 – Rule 12, and Rule 16 under Special rules. However, under section 3.1.4 of Med dev 2.4.1 rev 9 we see – 3.1.4. Active medical devices Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device. The concept “act by converting energy” includes conversion of energy in the device and/or conversion at the interface between the device and the tissues or in the tissues.
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Guidance for EU MDR - Software as a Medical Device (SaMD) And also under “Application of the classification of rules”: “Due to its complexity, classification of standalone software will be covered in a specific guidance document”. It is also worth defining here what an accessory is: ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device; The specific guidance document is Med Dev 2.1.6 “Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of Medical Devices”, however this is not reflective of the EU MDR 2017/745 and the IMDRF guidance documents. It is worth also looking at the definitions of a medical device in relation to software as per the MDD: Article 1 (Definitions and Scope) – MDD 93/42 EC 2. (a)‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
4.0 What is Software under the EU MDR? In this section we will begin to look at what the EU MDR 2017/745 describes regarding software. The definitions section is clearly different from the MDD so this shall be described and also compared in Appendix A in tabulated format which shows the MDD reference and the MDR reference and the difference between the two section by section. Using the following flowchart in fig 1.0 we decide whether our product is covered as a Medical Device under the EU MDR 2017/745, using the regulation itself and the definitions in the next few pages.
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Guidance for EU MDR â&#x20AC;&#x201C; Systems and Procedure packs
Contents 1.
Introduction .......................................................................................................................... 2
2.
Scope and Objective ............................................................................................................. 2
3.
What are systems and procedure packs under the MDD? ................................................... 2
4.
What are systems and procedure packs under the MDR? ................................................... 4
5.
Classification guidance .......................................................................................................... 6 5.a Classification of medical device systems and procedure packs under the MDD ................ 6 5.b Classification of medical device systems and procedure packs under the MDR ................ 7
6.
Checklist for manufacturers of medical device systems/procedures packs (MDR) ............. 8
7.
Examples of procedure packs under the EU MDR .............................................................. 10 Example 1 ................................................................................................................................ 11 Example 2 ................................................................................................................................ 12 Example 3 ................................................................................................................................ 13 Example 4 ................................................................................................................................ 14
8.
Appendices .......................................................................................................................... 15 Appendix A: MDD vs MDR for systems and procedure packs ................................................ 15 Appendix B: Table of relevant documents.............................................................................. 23
Guidance for EU MDR â&#x20AC;&#x201C; Systems and Procedure packs
1. Introduction The new EU MDR (2017), with a mandatory compliance date of 26 May 2020, replaces the former MDD (1993), and introduces new concepts, definitions and procedural requirements for medical device systems and procedure packs. Due to considerable advancements in the fields of surgery (particularly in specialised and precise surgical procedures), manufacturing and electronics there are now a much larger range of medical device products that would be considered as systems/procedure packs under the new regulations. Manufacturers of medical device systems and procedure packs, must carefully consider the new rules and regulatory requirements set forth within the EU Medical Devices Regulation 2017/745 (EU MDR), adopted by the European Parliament and Council in May 2017
2. Scope and Objective The aim of this document is to provide guidance regarding the classification and regulatory compliance of systems and procedure packs intended to be used as a medical device in accordance with the EU Medical Device Directive 93/42/EEC (MDD) and the new EU Medical Device Regulation 2017/745 (MDR).
3. What are systems and procedure packs under the MDD?
Guidance for EU MDR – Systems and Procedure packs While the MDD does not specifically define what a system or procedure pack is, it is clear from Article 12 of the MDD that it is the combination or assembly of medical devices that have CE marking approval and are proven to be compatible, considering their original intended use, for a specific medical purpose. If such conditions are met, and the devices will be marketed together as a system or procedure pack then the following applies: 1. The natural/legal person is required to draw up a statement/declaration stating that: •
The mutual compatibility of the devices has been verified in accordance to the manufacturer’s instructions and intended use
•
The system/procedure pack has been packaged with the relevant information supplied from the manufacturers to the user. All the activity regarding combination of devices is subject to the appropriate methods on internal monitoring and control
•
2. For devices designed by their manufacturer to be sterilised before use: •
Follow the procedures set out in Annex II OR Annex V of the MDD. (The scope of these procedures is limited to ensuring sterility until the package is either opened or damaged).
•
The natural/legal person must draw up a statement/declaration that serialisation was done in accordance to the manufacturer’s instructions.
3. Systems/procedure packs do not require an additional CE mark, however they do require: •
Information supplied by the manufacturer as per Annex I (13) of the MDD
•
The statement/declaration referred to above to be kept at the disposal of the competent authorities for 5 years
In the case that the conditions are not fulfilled then Article 11 applies instead, this can be due to: a. One or more of the devices in the system/procedure pack is NOT CE marked b. One or more of the devices in the system/procedure pack IS CE marked but not for the intended use of the system/procedure pack