Software

European Union: 

Software is defined as a set of instructions that processes input data and creates output data.

Software definitions per MDCG 2019-11 given,

 How to qualify the software as a medical device/in vitro diagnostic medical device software

Shall meet the definition of software according to the MDCG 2019-11 and the definition of a MD/IVD  according to Article 2(1) of MDR/IVDR

 MDR classification rules: Rules 9, 10, 11, 12, 13, 15 and 22 Annex VIII

IVDR Classification rules:To classify in vitro diagnostic medical device software all rules shall be considered.

EU Regulations References:

Is your software a Medical Device? Info graphic

MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

US FDA Software as Medical Device (SaMD)

“software intended to be used for more than one or more medical purposes that perform these purposes without being part of a hardware medical device.”

 How to qualify the software as a medical device/in vitro diagnostic medical device software

Meet the definition of software according Federal Food Drug & Cosmetic (FD&C) Act section 201(h) device definition.Some of the software functions are excluded from device definition.

 IMDRF Guidance documents.

Softwareas a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10FINAL:2013)

Softwareas a Medical Device (SaMD): Possible Framework for Risk Categorization andCorresponding Considerations (IMDRF/SaMD WG/N12FINAL:2014)

Softwareas a Medical Device (SaMD): Application of Quality Management System (IMDRF/SaMD WG/N23 FINAL:2015)

Software as a Medical Device (SaMD): Clinical Evaluation(IMDRF/SaMD WG/N41FINAL:2017)

 

Standards for Medical Devices

 Standards is a document, that is prepared by subject matter experts and approved by a recognized body.

This provides guidance on the design, use or performance of materials, products, processes, services, systems or persons.

International Standardisation Bodies 

• ISO: International Standardization Organisation (www.iso.org )
• IEC: International Electrotechnical Commission (www.iec.ch )
• ITU: International Telecommunication Union (www.itu.int )

European Standardisation Bodies

• CEN: European Committee for Standardisation (www.cen.eu)
• CENELEC: European Committee for Electrotechnical Standardisation (www.cenelec.eu)
• ETSI: European Telecommunications Standards Institute (www.etsi.org)

International standards are developed by International Standardisation Bodies.

ISO 14971:2019 Medicaldevices — Application of risk management to medical devices. 

European standards are developed by European Standardisation Bodies.

EN 60601-1-6:2010/A2:2021 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

European Harmonised standards

European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.

Harmonised standards are published in Official Journal of the European Union.

Devices that are in compliance with harmonized standards shall be presumed to be in conformity with the requirements of European Regulation. (Article 8)

US FDA Recognized Consensus Standards

FDA identify or recognize a standard established by a national or international standard developing bodies.Manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Guidance on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices

US FDA Recognized Consensus Standards Database:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

 

References

REGULATION (EU) No 1025/2012

REGULATION (EU) 2017/745

REGULATION (EU) 2017/746

Standards and Conformity Assessment Program: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices

MDR/IVDR Quality Management System (QMS)

MDR Article 10(10) have  QMS requirements.

MDR QMS  shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of MDR/IVDR.

Quality management system shall address at least the following aspects

Much already covered in ISO 13485:2016,but MDR QMS have some additional requirements ( some example :a strategy for regulatory compliance, including compliance with conformity assessment procedures and verification of the UDI assignments)

Source:

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

MDR/IVDR Certificate of free sale

Most of countries shall ask Certificate of Free Sale. This certificate is used for exporting the goods to another country.

Manufacturer or an authorised representative may request the Member State in which the manufacturer or the authorised representative has its registered place of business.

Certificate of free sale shall declare that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with this MDR/IVDR may be marketed in the Union.

Certificate of free sale include ,

• Basic UDI-DI of the device as provided to the UDI database under  MDR Article 29/IVDR Article 26.
• Unique number identifying the certificate issued by the notified body per Section 3 of Chapter II of Annex XII (Certificate of Conformity)

 Commission may, by means of implementing acts will provide  a model for certificates of free sale.

Source :

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

MDR/IVDR European database on medical devices (EUDAMED)

•  IT system developed by European commission
• Developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
• Improve the transparency
• Coordination of information regarding medical devices available on the EU market

Article 33 EUDAMED contains following 6 modules,

Electronic system	MDR Article	IVDR Article
Electronic system for registration of devices	Article 29(4)	Article 26
UDI-database	Article 28	Article 25
Electronic system on registration of economic operators	Article 30	Article 27
Electronic system on notified bodies and on certificates	Article 57	Article 52
Electronic system on clinical investigations	Article 73	MDR ONLY
Electronic system on performance studies	IVDR ONLY	Article 69
Electronic system on vigilance and post-market surveillance	Article 92	Article 87
Electronic system on market surveillance	Article 100	Article 95

Medical devices nomenclature

•        Article 26 of Regulation 745/2017 and Article 23 of Regulation 746/2017

•        Free of charge

•        internationally recognized

•        Future nomenclature should facilitate the establishment of links with the codes defining Notified Bodies competence (designation scope) , the scope of medical devices QMS (Quality Management System)/QA (Quality Assurance) certificates, and product portfolios in the mandate of Authorised Representatives.

•        Hierarchies by which terms and codes could be meaningfully grouped into categories and subcategories

•        Periodic review of nomenclature terms and descriptions, this shall be taken into account.

•        Classificazione Nazionale Dispositivi medici (CND)’ as the basis for the EMDN . CND is currently used in Italy, Portugal and Greece.

•         Revision of the CND is ongoing so that to release the first version of the EMDN

•         Commission will map the EMDN to the Global Medical Device Nomenclature (GMDN)

Guidance documents:

European Medical Device Nomenclature (EMDN)

Title	Publication
The EMDN – The nomenclature of use in EUDAMED	January 2020
The CND nomenclature – Background and general principles	January 2020
Future EU medical device nomenclature Description of requirements	MDCG 2018-2

 

EUDAMED

Title	Publication
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States	August 2020
Registration of legacy devices in EUDAMED	April 2019
Timelines for registration of device data elements in EUDAMED	April 2019

 Web Links :

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

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

Source :

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

MDR Systems and procedure packs

 MDR Definitions:

procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

system’ means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose;

Article 22(2) Statement :

System and procedure pack manufacturer shall prepare a statement to declare that,

• Mutual compatibility of the CE marked devices has been verified
• Packaged the system or procedure pack and supplied relevant information to users (Label and IFU)
• activity of combining devices was subject to appropriate methods of internal monitoring, verification and validation(sterilization)

They draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions.

Conformity assessment:

Notified body involvement is limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged.

apply one of the procedures set out in Annex IX or the procedure set out in Part A PRODUCTION QUALITY ASSURANCE of Annex XI+ Article 22 statement

System and procedure pack manufacturer contact details ( name, registered trade name or registered trade mark ) need to be included in labelling. Article 22 (2) shall be kept at the disposal of the competent authorities.

Cases in which System and procedure pack treated as a device in its own right:

• Devices which do not bear the CE marking
• Chosen combination of devices is not compatible in view of their original intended purpose
• Sterilisation has not been carried out in accordance with the manufacturer's instruction

Source:
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

MDR/IVDR General Obligations of Manufacturer / AR /Importer / Distributor

Obligations

Article 10 Manufacturer Obligations

Risk management system (Section 3 of Annex I)

MDR: Clinical evaluation including PMCF(Article 61 and Annex XIV) IVDR: Performance evaluation including PMPF (Article 56 and Annex XIII)

Manufacturers of devices other than custom-made devices: Technical documentation(Annex II & III)

MDR ONLY:Manufacturers of custom-made device: Documentation in accordance with Section 2 of Annex XIII.

Conformity assessment, Declaration of conformity (DoC) and CE marking (MDR Article 19 & 20/IVDR Article 17 & 18)

UDI system and registration obligations (MDR Article 27 ,Articles 29 and 31/ IVDR Article 24 ,Articles 26 and 28)

Retention period: Availability of Technical Documentation, Certificates and DoC

Quality management system

Post-market surveillance system (MDR Article 83/ IVDR Article 78)

Availability of information supplied by manufacturer

Vigilance system

Ensure implementation of corrective actions

Cooperate and coordinate with Competent authority

Registration of original equipment manufacturer in EUDAMED

Coverage of potential liability

 

 

Article 11 Authorised representative

Perform the tasks specified in the mandate agreed between Authorised representative and the manufacturer.

Verify the  EU declaration of conformity, technical documentation and Conformity assessment

Retention period: Availability of Technical Documentation, Certificates and DoC

Registration obligations and verify manufacturer registration obligations

Provide information / documentation to Competent Authority on request to demonstrate conformity in requested language

Forward to Manufacturer Competent Authority’s request for samples / access to a device and verify samples / access given

Cooperate with Competent Authorities in any preventive / corrective action to eliminate / mitigate risk

Immediately Inform Manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents

Terminate the mandate if the manufacturer acts contrary to its obligations

 

Article 13 General obligations of importers	Article 14 General obligations of distributors
Importers shall verify: a) Device CE marked and DoC b) Manufacturer identified & that an EU AR has been designated c) Device labelling d) UDI	Distributor shall verify: a) Device CE marked, DoC b) Device labelling c) For imported devices, the Importer name and address is on the label d) UDI Distributor may apply a sampling method to perform verification (except for b) Importer labelling)
If the device not in compliance with MDR then importer shall not place the device on the market + inform Manufacturer and EU AR	If the device not in compliance with MDR then importer shall not place the device on the market + inform Manufacturer, EU AR and Importer
Where the Importer considers the device presents a serious risk or is a falsified device, it shall inform Manufacturer, EU AR and Competent Authority	Where the Distributor considers the device presents a serious risk or is a falsified device, it shall inform Manufacturer, EU AR, Importer and Competent Authority
Add contact details to device or packaging or accompanying document
Registration obligations and verify manufacturer and device registration obligations
Safeguard storage and transport conditions	Safeguard storage and transport conditions
Keep register of complaints,non-conforming devices, etc. Provide Manufacturer, EU AR and Distributors with any information requested in order to allow investigation of complaints	Keep register of complaints, non-conforming devices, recalls and withdrawals • Keep Manufacturer, EU AR and Importers informed of monitoring and provide any information upon request
If the device presents a serious risk then they shall immediately inform the Competent Authorities and the Notified Body. Co-operate with the Manufacturer, the manufacturer’s EU AR and the Competent Authorities to ensure that the necessary corrective action, withdrawal or recall is taken	If the device presents a serious risk then they shall immediately inform the Competent Authorities and the Notified Body. Co-operate with the Manufacturer, the manufacturer’s EU AR, Importer and the Competent Authorities to ensure that the necessary corrective action, withdrawal or recall is taken
Immediately Inform Manufacturer and EU AR about complaints and reports from healthcare professionals, patients and users about suspected incidents	Immediately Inform Manufacturer ,EU AR and Importer about complaints and reports from healthcare professionals, patients and users about suspected incidents
Retention period: Availability of Technical Documentation, Certificates and DoC
Cooperate with Competent Authorities, on any action taken to eliminate / mitigate the risks	Distributors shall, upon request from a Competent Authority, provide information and documentation necessary to demonstrate the conformity of a device (unless the Manufacturer or EU AR has done so) Distributors shall cooperate with Competent Authorities, on any action taken to eliminate / mitigate the risks posed by devices which they have placed on the market
Importer shall provide samples of the device free of charge to the competent authority	Distributors, upon request of a Competent Authority, shall provide samples of the device free of charge / grant access to the device

 

Source:

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU