Free Seminar – Incident Reporting/PMS

Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market.

Information
After years of development and testing, bringing your medical device to market is an exciting achievement. 

However, your work isn’t finished yet. Once your product is in the hands of the public, you must ensure it continues to meet the needs of patients and healthcare providers. This is where post-market surveillance (PMS) comes into play.

Speaker
QAdvis newest consultant with previous experience from Läkemedelsverket, Marie Mathiasson.

Date/Time
13 June, 14.00 – 15.00 including Q&A

Welcome to a pre-chat with coffee and cake (get some Swedish fika) from 13.30, meet our speaker and mingle with other industry colleagues. 

Location: Medicon Village
The main reception is located in The Spark at Scheeletorget 1 in Lund. More detailed information will be sent to you the day before the event.

Register at Eventbrite

Note: The event is free but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. (If you register but don’t attend, you will be charged 200 SEK.)

If you have any question, contact us at info@qadvis.com.

Will AI replace your doctor?

AI enabled medical devices are increasingly making their way into every sector of the medical profession, supporting decision-making that could potentially affect life or death for patients. As these technologies improve, a pressing question emerges: Should we trust AI or the doctor?

AI enabled medical devices are becoming more prevalent and powerful, raising new challenges and ethical questions regarding human oversight and responsibility. We accept human mistakes as inevitable, yet we hold AI to higher standards. According to the WHO ethical principles, AI should not replace human decision-making, but rather augment it, and humans should always have the final say on health matters. But when AI outperforms doctors, which should we trust more?

Device manufacturers currently try to avoid liability issues by stating for example, that the AI does not make a diagnosis, it is only a suggestion etc., but we all know that we humans tend to take the least burdensome approach, especially under stressful conditions. This could especially be a risk with younger, less experienced medical staff. If the AI was correct in 99 cases out of a hundred, why wouldn´t it be right on the hundredth too? Studies suggest that AI could indeed reduce misdiagnosis rates, especially for rare diseases, where only the most skilled doctors can match the ability of AI.

Interestingly, some AI systems can now monitor a doctor’s surgical performance and suggest technique improvements during operations. This raises the question: Who is monitoring whom?

There are numerous questions to address to ensure that AI-enabled medical devices can maximise their potential benefits while minimizing their potential risks. With a clear and consistent framework for assessing and regulating AI-enabled medical devices, we can put our trust in them – or rather in the people that made them.

Will AI then replace doctors? Well, there’s a famous saying – Its origin unclear – that AI is not going to replace your doctor, but the doctor using AI will replace the one who doesn’t.

If you have any question, contact us at info@qadvis.com.

Importers and Distributors: Pivital roles in MDR and IVDR Compliance

There is a common misconception that only manufacturers need to comply with the Medical Device Regulation (MDR) 2017/745 and/or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) . However, MDR/IVDR defines the roles and the responsibilities of “Economic Operators” which includes Importers, Distributors, Authorized Representatives and Manufacturers.

An Importer means any natural or legal person established within the Union that places a device from a third country (meaning outside EU) on the Union market and is designated by this symbol on the labelling. The Importer must also register their company in the  European Database on Medical Devices (EUDAMED).

A Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service. EUDAMED registration is not required.

An Authorized Representative (EC-REP) is any natural or legal person established within the Union that acts as the manufacturer’s regulatory representative in the Union and as the point of contact between the manufacturer and the National Competent Authorities. The EC-REP is designated by this symbol on the labelling.

MDR/IVDR Article 13 describes many of the general obligations of importers. One of the fundamental tasks for an importer is to ensure that the medical devices they import and/or distribute bear the CE mark. They are also responsible for labelling their name, address, or trademark on the device alongside the manufacturer’s information. The importer must also make sure that an Authorized Representative is appointed and they are required to report incidents or adverse events to relevant authorities or notified bodies.

They are also responsible for ensuring correct storage and handling of medical devices and maintaining documentation, such as certificates of conformity, shipping documents, and others. Additionally, importers must establish procedures for monitoring the performance and safety of the medical devices they import. The importer must verify that devices are registered in EUDAMED and ensure a Unique Device Identification (UDI) has been assigned where applicable.

Distributors must follow similar rules to importers, as outlined in MDR/IVDR Article 14. One key difference is that while distributors also need to ensure correct labeling according to MDR/IVDR, they are not required to label the products with their own information. Distributors must establish processes to ensure the integrity and reliability of their supply chain. This includes conducting due diligence on manufacturers and suppliers to verify compliance with MDR requirements.

Apart from the general obligations, Article 16 of the MDR/IVDR also specifies that importers and distributors must have an appropriate quality management system in place that complies with the requirements. Additionally, they may be subject to local Competent Authority requirements in some scenarios.

In summary, distributors and importers in the MedTech industry carry vital responsibilities. They ensure compliance with regulations and facilitate the safe and effective distribution of medical devices to healthcare providers and patients. Each stakeholder plays a crucial role in meeting regulatory requirements and maintaining product traceability throughout the supply chain.

The below is a condensed list of the requirements for Importers and Distributors. The list does not encompass all of the requirements so please refer to MDR/IVDR for the complete text.

The Importer shall:

  • Ensure that the devices they place on the market bear the CE marking.
  • Ensure that devices are accompanied by the required information, are labeled in accordance with the Regulation, and have been assigned a UDI where applicable.
  • Verify that devices are registered in EUDAMED.
  • Ensure that storage or transport conditions comply with the conditions set by the manufacturer, when under their responsibility.
  • Inform the authorities if they suspect that a device has been falsified, poses a serious risk to health, or is non-compliant.
  • Add their name, registered trade name or trade mark, registered place of business, and contact address either on the device or its packaging, or in a document accompanying the device.
  • Keep a register of complaints, non-conforming devices, recalls, and withdrawals, and escalate non-compliance to authorities.
  • Cooperate with authorities by providing samples or granting access to the devices.

The Distributor shall:

  • Verify that the devices have been CE marked, that an EU Declaration of Conformity has been drawn up, and that labels and instructions for use in acceptable languages are available.
  • Verify that the importer’s name is indicated on each device or in the accompanying documentation, and that the device bears a UDI.
  • Ensure that storage or transport conditions comply with the conditions set by the manufacturer, when under their responsibility.
  • Inform other economic operators and authorities if they suspect that a device has been falsified or poses a serious risk to health.
  • Keep a register of complaints, non-conforming devices, recalls, and withdrawals.
  • Cooperate with authorities by making all the documentation and information they have at their disposal available, and provide samples or grant access to the devices if requested.

If you have any question, contact us at info@qadvis.com.

We strengthen our team.

A warm welcome to Marie Mathiasson, our new team-member in Kista

QAdvis is happy to welcome Marie to our growing team of experienced quality and regulatory consultants. Marie has an extensive background in regulatory compliance within the medical device sector. She has previously worked at the Swedish Medical Products Agency as an investigator of post market surveillance and navigated complex vigilance reporting cases, including CAPA and FSCA. She has broad experience in risk assessments for both medical devices and In-Vitro diagnostic devices. This strategic expansion is a testament to our commitment to continuous growth and to meet the current and future quality and regulatory requirements throughout the development, market launch and the post market surveillance of medical devices.

If you want to learn more about Marie and her experiences and how QAdvis can contribute to your business, contact us at info@qadvis.com or call us at + 46 86 21 01 05.