Requirements of Technical Documentation EU MDR

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745.

Requirements as per Annex II

  1. Device description and specification, including variants and accessories
  2. Information to be supplied by the manufacturer
  3. Design and Manufacturing information
  4. General safety and performance requirements
  5. Benefit-risk analysis and risk management
  6. Product verification and validation

Device description and specification, including variants and accessories

This section mentions that technical documentation must include all basic device details such as trade name, general description, Basic UDI-DI, principles of operations, classification details, accessories description, key functional elements, technical specification etc. There must also be a proper reference to previous or similar medical devices.

Information to be supplied by the manufacturer

This section mentions that manufacturer must include a complete set of labelling for the device and its packaging. The manufacturer must also ensure the language requirements of the same according to the each member states’ language requirements.

Design and Manufacturing information

This section mentions that the technical documentation shall include complete information on processes carried out by the manufacturer during the design stage, manufacturing, validation, monitoring and final product testing of the device. Identification details of all sites and people involved in the manufacturing process must also be made available.

General safety and performance requirements

This section mentions that the technical documentation must demonstrate conformity to general safety and performance requirements set out in Annex I of the MDR. This shall include details such as an explanation for safety and performance requirements that the device satisfies and an explanation for requirements that it does not meet, methods used to demonstrate conformity, harmonized standards, Common specifications, and the identity information of the control documents.

Benefit-risk analysis and risk management

This section mentions that the technical documentation shall include the benefit-risk analysis, solutions adopted, and risk management results as per Annex I of the MDR. Some significant points from the Risk management section of Annex I are

  • The risk management plan must be available for each device
  • Should be able to identify foreseeable hazards associated with each device
  • should be able to estimate and evaluate the risks
  • should have plans to eliminate/control the risks
  • should be able to assess the impact of risk at various stages of the device’s lifecycle and thereby estimating overall risk, benefit-risk ratio, and risk acceptability

Section 1 to 8 of Annex I gives detailed information on general safety measures and other risk management requirements.

Product verification and validation

This section mentions that the technical documentation shall contain results and critical analyses of all verification and validation tests/studies. Some significant Tests/studies discussed in the section are

  • Biocompatibility
  • Electrical Safety
  • Electromagnetic compatibility
  • Software verification and validation
  • Stability
  • Performance and Safety
  • Physical, chemical, and microbiological characteristics
  • sterility

A clinical evaluation report and a PMCF (Post-market clinical follow-up) plan and evaluation report must be available. Else, a justification for why PMCF is not applicable must be made available. Additional information required in specific cases is given in detail in Section 6.2 of Annex II of the EU MDR.

Post-Market Surveillance

Annex III of the MDR majorly mentions that the post-market surveillance plan must address the method of collection and utilization of available data (Such as information on serious incidents and their corrective actions, data on any undesirable side- effects and so on) and includes a list of details a post-market surveillance plan must include in the plan. There is also a reference to PSUR (Periodic safety update report) and post-market surveillance report mentioned in articles 86 & 85, respectively.

Significant Changes to be noted during the transition from MDD to MDR

  1. Device description to include UDI, UDI-DI or any such number for traceability reasons
  2. Reference requirements to previous or similar medical devices
  3. Under labelling requirements in the MDR, it is explicitly talks about the labelling of devices and their packaging
  4. Language requirements for labelling
  5. As per the MDD, only Class III devices required an explanation for design stages and procedures. The same is now updated to all classes of medical devices in MDR
  6. Identification requirements of all manufacturing sites, design including suppliers and contractors are required now
  7. General safety and performance requirements are updated versions of Essential requirements from the MDD
  8. The benefit-risk analysis is explicitly mentioned as part of risk management requirements in the MDR
  9. Product verification and validation requirements
  10. A detailed explanation of pre-clinical and evaluation and Clinical Evaluation requirements are provided in the MDR
  11. The requirements of the Clinical Evaluation plan and report, Post-market clinical follow-up plan and report are specially mentioned in the MDR
  12. Additional information for special case devices (e.g., combination device, sterile device, device with measuring function etc.) is mentioned in detail in the MDR

FAQs:

What are Common specifications?

Common Specifications are a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

What is the UDI?

The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere
in the world.

What is the Basic UDI-DI?

Basic UDI-DI is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item

Is Post-market surveillance (PMS) applicable for only higher risk classes?

PMS is required for all device classes. A PMS plan and report to be maintained and kept updated by the manufacturer throughout the device life cycle.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

“Professional use” Test Kit – Procedure for registration in UK 

“Professional use” Test Kit – Procedure for registration in UK 

Professional use” Test Kit – Procedure for registration in UK 

Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020.

One of the most difficult aspects of coronavirus is the ambiguity of not knowing who has been infected or whether it is safe to resume normal activities. Testing of high quality might assist provide assurance. However, no good thing in the world has ever been without challenges. Accuracy and reliability of the tests, getting the right supply of people, lab space, equipment and chemicals, and logistics has proven to be the major hurdles in the testing procedures. Nevertheless, governments across the globe are striving to cope up with these challenges for bettering the lives of the masses.

Out of a variety of Tests available in the UK Market, a Professional use test kit, as the name suggests, is intended to be used by the professionals. By professionals, it means the kits to be used by personnel who have obtained specialized training and education in processes involving in-vitro diagnostic medical equipment, such as laboratory personnel, trained clinicians, and qualified healthcare professionals. This kit must be UKCA, or CE marked, and must be categorized as general IVD as per the amended UK MDR 2002. If the manufacturer of a professional use COVID-19 test expects the test kit to be used in an assisted or supervised testing condition, the IFU should state so, and there should be documentation of performance statistics to back up this claim.

Talking about the test kit regulations as per UK’s Ministry of Health – Medicines and Health products Regulatory Agency (MHRA), no antigen or molecular detection COVID-19 (SARS-CoV-2) test may be placed on the UK market without first being verified against minimal performance standards through a Coronavirus Test Device Approvals (CTDA) desktop evaluation, according to regulation 34A of the Medical Devices Regulations 2002. Manufacturers or distributors supplying COVID-19 test kits must apply to the Department of Health and Social Care (DHSC) for approval and their product must meet The Medical Devices (Coronavirus Test Device Approvals) Regulations 2021. The MHRA will not accept registration applications for covid test devices until they have obtained CTDA approval or have been placed on the Temporary Protocol list. If the manufacturer believe equipment is exempt from the CTDA Regulations 2021 and want to register it with the MHRA, manufacturer will most likely be contacted to explain the exemption applicable in the regulations before the MHRA registration application is accepted.

Steps for applying to CTDA approval 

Step 1: Submitting the application 

Make sure to provide the below data properly: 

  • Manufacturer and product information 
  • Regulatory status 
  • Product performance 
  • Biosafety 
  • Supplementary documents (for example: current version of the instructions for use, biosafety documents, evidence of performance characteristic) 

Step 2: Desktop Review – It is the assessment of the evidence submitted by a supplier against a minimum required data set. This stage prohibits products to reach the market that do not meet the expected criteria from the CTDA Regulations 2021. 

The main areas of assessment are below: 

  1. Manufacturer and test information  
  2. Regulatory status 
  3. Intended use case 
  4. Product performance 
  5. Biosafety 

(Note: If you require a complete checklist of the above areas of assessment, mail to [email protected]

DHSC generally produces the results within 20 working days, but can take longer depending on the availability, and applications volume. If DHSC contacts for more information, it must be responded in 20 working days, else the application might be rejected. 

For the approval, it is mandatory to pay the fees, depending on the size of the company applying for validation. The price for desktop review is £6,200 if the company has no more than 250 individuals in total. Otherwise, the cost is £14,000. 

DHSC only publishes details of tests that have passed, showing: 

  • Indicative performance category 
  • Name of the test 
  • Name of the manufacturer and business address 
  • Name and business address of person who made application (if different to the manufacturer) 
  • Date and version for instructions of use 
  • Type of test 
  • Date of approval 
  • CE certification number 
  • Country of manufacture 
  • Sample type 

If the application is unsuccessful, a request to DHSC for reconsidering its decision can be made using the web form in the service. 

Labelling Requirements

Labelling Requirements

Economic OperatorSwissEUUK
AR/RPCH REP on the product label. Name Address of the registered place of business. Deadline: MDD: 26/05/2021 MDR: 26/05/2021 (if applicable depending on transition period)

OMC Swiss AR Address: OMCS Medical Gmbh C/O Mr Wilhelm Gudelow Aegeristrasse 5 6300 Zug  
EU AR on the product labelNameAddress of the registered place of business.Deadline: 26/05/2025          

OMC EU AR Address: OMC Medical Spolka, Z Organiczona, Pegaz, 3rd Floor, Building B, Grabarska 1st str. Wroclaw, 50-079  
UK Responsible person on the product label for UKCA marked devices only. Name Address of the registered place of business deadline 30/06/2023   No specific symbol required  

OMC UK RP Address: OMC Medical Limited, Planet House, North heath lane, Horsham RH12 5QE.  
ImporterCH Importer on the product, product packaging or a document enclosed with the product. NamePlace of business contact address Deadlines: MDD: 31/07/2022 MDR: 26/05/2021   Note: Swissmedic requires the CH importer to be stated from 31.07.2022 if: EU interpretation has not been published by then.Swissmedic recommendation implementation from 26.05.2021Importer on a device or its packaging or in a document accompanying the device.NameRegistered trade name or registered trademark.Registered place of business and contact address.Deadline: 26/05/2025No Labelling requirement at this stage.
Compliance symbol What is CE Marking? - CE Mark Certification vs. Self Declaration | ASQWhat is CE Marking? - CE Mark Certification vs. Self Declaration | ASQUKCA marking - Wikipedia
Dual labelling is allowed in the UK so that you can have both CE and UKCA marking on your products.

 

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative

Label

Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.”

The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III). For imported devices, the CH-REP should be indicated according to the below table:

Device ClassCH-REP Symbol / Indication to be placed on
Class I MDR DeviceWith effect from 26 May 2021 Until 31-Jul-2023 Where: Either on the label (or) On the Document accompanying the device After 31-Jul-2023 Where: On the label
Class IIa, IIb, III MDR DevicesWith effect from 26 May 2021 Where: On the label
MDD/AIMDD Devices with EU/EEA manufacturer or EC-REPWith effect from 26 May 2021 Where: MDD – On label (or) Instructions for Use (or) In Document accompanying the device   AIMDD – On sales packaging (and) Instructions for Use (or) In Document accompanying the device
MDD/AIMDD Devices without EU/EEA manufacturer or EC-REPWith effect from 26 May 2021 Where: MDD – On label (or) Instructions for Use   AIMDD – On sales packaging (and) Instructions for Use

“CH-REP” Symbol

Representation / Usage of the “CH-REP” Symbol on the Device packaging

  • The name of the Swiss AR must be available on the product label.
  • The Name and Address of the Authorised Representative (AR) must appear adjacent to the symbol.
  • The mentioned Address must enable provision to contact the Swiss AR with sufficient contact details.
  • The symbol’s size and name are not defined; however, they must be adequately visible to the naked eye.

Symbols to Use

Where symbols are used, they must conform to the harmonised standards. Swiss medic rule allows the sole use of the symbol without any description of the symbol explained in the product documentation enclosed.

Other CH-REP Representation(s)

Instead of the symbol, Swiss medic also permits the indication as stated below:

“CH-Authorised Representative”

“CH-REP”

“Authorised Representative for Switzerland”

Rules for Manufacturers from EU/EEA

Manufacturers placed in the EU/EEA also fall under this obligation to appoint their Swiss AR (called CH-REP or Swiss Rep or SAR). It is least expected that a single CH-REP is appointed for devices that belong to the same medical device group or family.

Source Reference Links

MedDO Ordinance – Swiss MedDO 812.213

MedDO Article 51 – Obligations of Swiss AR

MedDO Article 104a – Timeline to Appoint AR

Swiss Medical Device Labelling Requirements – Chapter III of Annex I to EU-MDR 2017/745

FAQs

What does “In a document accompanying the device” mean and where should I make this information available?

This information can be affixed to the device or be available separate from the device. Available separate refers to documents such as delivery notes, customs documents, guarantee certificates, invoices, a sticker on the packaging or the instructions for use.

Such documents are made available with the device throughout the supply chain route. It is available until it reaches the distributors and need not be necessarily available to the end customer. Note that this accompanying interpretation differs from the Swiss with EU MDR.

Is the definition of a “document accompanying the device” of Swiss MedDO and Europe’s MDR 2017/745 the same?

No, they are not the same. The interpretation of document accompanying the device definition differs from Swiss MedDO and EU MDR.

In what languages must the medical device product information such as Labelling and Instructions for Use be written for the Swiss market?

It must be written and made available in all three official languages of Switzerland (German, French and Italian). Symbols established by using technical standards may be used to replace the written statements.

Swiss MedDO Information sheet on Economic Operators

What are the other obligations of a Swiss AR / CH-REP?

A detailed obligation/responsibilities of a CH-REP are available in our article Obligations of the Swiss Authorised Representative.

Who are the Economic Operators required to be registered with Swiss medic?

  • Manufacturers (or) their Swiss Authorised Representative must register themselves within three months of placing the device for the first time in the Swiss market.
  • During registration, they must cater information as per Part A of Annex VI EU MDR 2017/745. Further obligations and registration modalities are governed by Article 30 and Article 31 of EU MDR 2017/745
MEDICAL DEVICE REGISTRATION IN ROMANIA

MEDICAL DEVICE REGISTRATION IN ROMANIA

How OMC Medical can assist you with the process

  1. Act as your Romanian AR
  2. Help you with the Romanian registration by filling in the form and registering the medical device with the NAMMD authorities.
  3. Translate your documents to Romanian for submission.

Regulatory Authority: National Agency for Medicines and Medical Devices of Romania

Link for MoH: https://www.anm.ro/en/

Local Listing or Registration: Yes, Local listing is required.

Local regulation: Romanian law

Medical devices concerned:

  1. Class I medical devices, including sterile and / or measuring devices;
  2. Custom-made medical devices and custom-made active implantable medical devices;
  3. Systems and procedure packages referred to in Article 29 of Government Decision no. 54/2009;
  4. In-vitro diagnostic medical devices.

Data to be communicated to NAMMD:

  1. Notification Identification data
  2. Manufacturer Identification data
  3. Identification data of the authorized representative
  4. Medical device identification data
  5. Attached documents

Who should make this communication:

  1. Manufacturers
  2. Authorised representatives