Regulatory requirements are a design input.

What is the purpose of developing a medical device?

If you ask your employees, the probable answer is that it is to help patients and fulfill user needs. Which is fair enough, but in order to do that we also need to understand that regulatory and government authorities also are included in the “user needs”.

At the core of every design and development process are the user needs. Too often, however, the user needs are limited to the needs of the patients and/or health care professionals. Regulatory requirements are overlooked except for the immediate market where the manufacturer resides. Your device is CE-marked or 510(k) cleared but the needs on important markets are not included in the design input. This sometimes causes registration problems, costly redesigns, retesting or even registration failure.

Failure in design transfer to production is one of the most common sources of FDA warning letters which has led manufacturers to understand that you cannot just design the product and then throw the drawings over the wall to production and hope everything will be sorted by itself. You need to work together as a team.

Unfortunately, this is still often the case when it comes to registrations. The requirements from the applicable markets are investigated at its best at the design release and a world of trouble opens up causing changes, delays and additional costs. This can however be avoided to a large extent just by understanding that the regulatory requirements are essential in design input

Initial sales strategy
Early in the process an initial sales strategy should be presented with intended use, intended users and the most important markets. The strategy should also include the anticipated sales for the first 3-5 years if possible. Depending on the type of device, health economics and reimbursement requirements should also be investigated.

Regulatory route
The regulatory department can then do an initial assessment of the requirements of each of the proposed markets. This should include the cost and complexity of the registration as well as additional local requirements such as:

  • Classification
  • Product codes
  • Additional labelling requirements?
    • Translations
    • Country specific symbols/labelling needed.
  • The need for a local market representative?
  • Additional QMS requirements including foreign government audits?
  • Additional manufacturer registrations needed?
  • Local standards or testing required?
  • Other local regulations that could affect device registration (radio, battery, animal content)
  • Local demographics required for Clinical or Usability investigations?
  • Should health economics be included in the Clinical study?

With the information above, a cost/benefit analysis can be performed and an informed decision on which markets to pursue and which requirement to include from the start can be pursued. This way the device will be ready for major applicable markets at release rather than trying to squeeze them in later stages.

A successful product realization and launch can be summed up with the famous Plan, Do, Check, Act. However, as you can see, the first word is Plan.

ISO 13485:2016 Certification achieved!

We are delighted and proud to announce that QAdvis Group has achieved ISO 13485:2016 certification. This is a major milestone and demonstrates our commitment to provide high quality consulting services and we are now better positioned to consistently meet and exceed our clients’ expectations.

Welcome to us Kecke Elmroth

With a solid background from Medical Affairs in MedTech industry and academic Life Science research, Kecke is skilled in clinical/scientific reading, writing, and interpretation. She is well-experienced in clinical evaluation, post-market clinical follow-up, clinical evidence gap identification, systematic literature search, and claims substantiation for regulatory purposes. Kecke is used to provide Medical Affairs input to Technical Documentation, risk assessment, product design development projects, clinical study strategies and marketing material.

Appreciated for being a direct and service-minded self-starter with high personal standards, professional integrity and strong focus on the end-product, Kecke is a knowledgeable partner, always prepared to work around issues to find solutions.

Kecke is part of the Lund office team but most of the time you will find her in her home-office in Mölndal.

Is UDI for medical devices as complicated as it seems?

Purpose of implementing a device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities.

UDI, Unique Device Identifier, is a unique numeric or alphanumeric code that relates to a specific medical device. UDI allows a clear and unambiguous identification of a specific device on the market and facilitates traceability during it’s entire lifecycle.  Currently there are 4 issuing entities that are designated to provide manufacturers with a list of UDIs to assign on their medical devices[1]

The UDI combines different information about the device itself and the legal manufacturer information. Purpose of implementing this device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities. UDI is an addition to, and not a substitute for, the existing labelling information and applicable requirements.

The legal manufacturer shall assign the UDI to the device and to all higher levels of packaging before placing a device on the market. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging. Within the EU, the manufacturer also need to assign a Basic UDI-DI. The Basic UDI-DI is the main key for device-related information entered in European medical device database (EUDAMED). The Basic UDI-DI shall be included in relevant documentation e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance.

Basic UDI-DI
A 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.

The Basic UDI-DI shall not be confused with the UDI-DI.

Key differences between Basic UDI-DI and UDI-Di are clarified in below table[2]

[1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019D0939

[2] https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/overview-of-the-eu-basic-udi-di

A new UDI shall be assigned whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability, in particular in following changes.

  • name or tradename
  • device version model
  • labelled as single use
  • packaged sterile
  • need for sterilization before use
  • quantity of devices provided in the packaging
  • critical warnings, contraindication

UDI-DI and UDI-PI
The difference between UDI-DI (device identifier) and UDI-PI (production identifier) is the type of information that need to be included.

  1. UDI-DI is a fixed code that relates to a specific version or model of a device.
  2. UDI-PI, is a variable code that relates to production data of the device, such as lot/batch number, expiry date, manufacturing date, etc.

The UDI-carrier, Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) shall be placed on the label or on the device itself and on all higher level of packaging.

A UDI consists of a combination of a Device Identifier as unique identifier (product code/GTINs) and one or more Production Identifiers (Application Identifiers (AIs)).

Example:

The UDI must appear in a plain-text version/human readable information (HRI) and in a form that uses AIDC technology. AIDC means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or another computer system via an automated process. HRI consists of legible characters that can easily be read by people.

Labelling specification
To ensure that your medical device fulfill the labelling requirements defined in the MDR and IVDR regulations you should start with development of a procedure there you define applicable requirements for your organization and for the type of product you place or intend to place on the market. The procedure should also define which type of information (product/packaging label, Instruction for Use (IFU), maintenance/service information and marketing material) you need to supply with your device and how it need to be supplied. Remember that the supplied information, including information for safety, are related to the result from the performed risk assessment.

Below table is an example of how to document MDR requirements, packaging levels and how it can be related to the UDI-DI and UDI-PI.

 

Have in mind that countries outside Europe for example USA, Kina, Korea and Saudi Arabia also require UDI, but they may not accept all UDI issuer entities as in Europe.

If you have any question or need support with writing your procedure and/or to identify applicable labelling requirements for your organization and your device(s), just send me an email, annelie.hagstrom@qadvis.com

See https://webgate.ec.europa.eu/udi-helpdesk/?lang=enEU for more information from the EU Commission.