New reporting requirements for medtech products

What are the changes?

The Medical Products Agency has clarified that all economic operators supplying medical devices on the Swedish market are affected, but only manufacturers (or if there is an authorized representative) must report deficiencies and interruptions in supply to the agency. Others are responsible for passing on the information in the supply chain

This obligation is regulated in Article 10a of the MDR as well as in the IVDR and covers devices where an interruption would cause serious harm, or a risk of serious harm, to patients or a risk of deterioration of public health.

The reporting shall take place as follows:

• At least six months before a planned interruption or cessation of supply.
• Immediately in case of an unplanned outage.
• The form to be used for reporting is called MDCG 2024-16

The rules apply in particular to products such as:

• are necessary for healthcare in one or more EU countries
• Requires continuous access to ensure the health and safety of patients.
• Lack of available alternative products.

För att uppfylla de nya kraven måste företag ha tydliga rutiner för leveranstid, riskbedömning, compliance och transparens i hela supply chain samt ha processer för att proaktivt kunna fånga upp ett leveransstopp.

What challenges does the industry face?

Hur säkerställer då företag att de inte drabbas av plötsliga avbrott och kostsamma konsekvenser? Företag inom tillverkning av medicintekniska produkter (vilket även innefattar den som legalt är ansvarig tillverkare, även om man tex har outsourcat sin produktion) står inför flera utmaningar i implementeringen av de nya reglerna:

• Interpretation and compliance: The rules require careful understanding and adaptation of internal business processes.
• Risk assessment and predictability: Predicting supply disruptions six months in advance can be difficult, especially in the case of global supply chain disruptions.
• Effektivisering av interna processer: Företag måste utveckla robusta system för att övervaka och hantera eventuella brister i leveranskedjan.
• Communication and transparency: Effective information sharing between authorities, distributors, healthcare providers and patients will be crucial to reduce the impact of critical interruptions.

"One major challenge I see is how to assess whether a delivery stoppage falls within the scope of Article 10a. You usually have to take into account a number of different aspects depending on whether the product is a consumable item or whether it is used over a period of several years, and there are also some exceptions where you generally do not need to report (for example, if the interruption is less than 60 days, or if the manufacturer or other manufacturers sell equivalent products)," says Johanna Kilegran, Compliance Consultant at Plantvision.

Consequences of inadequate situations

Vad händer om en kritisk medicinteknisk produkt plötsligt blir otillgänglig?

Failure to comply with reporting requirements can have far-reaching consequences:

For the company:

• Risk of regulatory action such as warnings, fines or suspension of licenses.
• Negative impact on the reputation and trust of customers and patients.
• Economic losses due to deteriorating market position and sanctions.
• Non-compliance leads to loss of market share.

For society and healthcare:

• Shortages of critical medical devices can create serious problems for patients and healthcare systems.
• Increased strain on the health care system, which can lead to longer care times and higher care costs.
• If deficiencies affect products without available alternatives, it can have life-threatening consequences for patients.

For the individual:

• Patients can be denied critical care due to product deficiencies.
• Increased risk of complications, deterioration of health and, in the worst case, life-threatening situations.

Opportunities for businesses to be proactive

Despite the challenges, the new rules also present opportunities to strengthen operations:

• Improved supply chain management through more structured and predictable processes.
• Increased transparency creates better relations with authorities and healthcare providers.
• Innovation och digitalisering kan hjälpa företag att utveckla mer effektiva lösningar för att hantera leveransrisker.
• Att ligga i framkant med compliance och riskhantering kan ge en konkurrensfördel och stärka företagets position som en pålitlig aktör.

Summary

With the new MDR and IVDR reporting requirements in Article 10a, it will be crucial for companies in the Medtech industry to have well-functioning supply chain security, risk assessment and transparency procedures in place. By proactively adapting to the regulatory framework, companies can not only avoid risks, but also create long-term benefits and contribute to more sustainable and safe healthcare.

Read more at the Medical Products Agency