Regulatory framework governing the distribution of medical devices by Nordic Research Accessories AB.

Regulatory framework

Nordic Research Accessories AB operates as a medical device distributor within the European Union. All distribution activities comply with the binding regulations applicable to Sweden and the broader EU/EEA single market.

Distribution scope

The company distributes medical devices and non-medical accessories across the risk classes defined by MDR Annex VIII classification rules — primarily Class IIa and Class I devices, alongside adjacent non-medical accessories. The distinction between medical devices and non-medical accessories is maintained in product labeling, customer communications, and catalog organization.

MDR Article 14 obligations

Article 14 of MDR 2017/745 defines the obligations of distributors. Our operational procedures address each obligation:

1. Verification of conformity. Before placing a device on the market, we verify that the device bears CE marking, has the EU Declaration of Conformity drawn up by the manufacturer, is accompanied by the required information per Article 10(11) MDR, and where appropriate has a UDI assigned per Article 27.
2. Storage and transport conditions. Devices are stored and transported under conditions established by the manufacturer. Temperature-sensitive products are tracked through controlled-temperature logistics. Storage facility conditions are monitored and recorded.
3. Traceability. Lot numbers, expiration dates, and shipment destinations are recorded for all distributed devices. Records are retained for the duration required by Article 10(8), minimum 10 years after the last device is placed on the market.
4. Cooperation with authorities. Upon request from Läkemedelsverket or other competent authorities, we provide samples of devices, access to records, and any other information needed to demonstrate conformity.
5. Vigilance system participation. We forward complaints and incident reports received from healthcare professionals, patients, or users to the relevant manufacturer without delay, and inform the competent authority where required.
6. Information transfer. Information about field safety corrective actions issued by the manufacturer is forwarded to relevant customers.

Quality management system

The company maintains a quality management system aligned to ISO 13485:2016 principles. While ISO 13485 certification is primarily required for manufacturers, our distributor operations follow the standard's principles to ensure consistency in supplier qualification, document control, and post-market surveillance.

Quality management procedures include:

• Document and records control with controlled access and version management
• Supplier qualification and annual re-evaluation
• Incoming inspection of devices upon receipt at distribution facility
• Storage and handling per manufacturer specifications
• Customer complaint capture and forwarding to manufacturer
• Annual management review of quality system performance
• Continuous improvement of operational procedures

Vigilance and post-market surveillance

Distributors contribute to the medical device vigilance system per MDR Articles 87–92. Our role is defined as follows:

• Complaint reception. All customer complaints, reports of malfunction, or incidents are documented in our complaint management system within one business day of receipt.
• Manufacturer notification. Complaints are forwarded to the relevant manufacturer without delay, with all available information attached (device identification, batch number, complaint details, user information where consented).
• Authority notification. Where a complaint relates to a serious incident as defined in MDR Article 87, we notify Läkemedelsverket directly in parallel with the manufacturer notification.
• Field safety corrective actions. When a manufacturer issues a Field Safety Notice (FSN) or initiates a Field Safety Corrective Action (FSCA), we cooperate fully and forward all relevant information to affected customers.
• Post-market surveillance support. We provide manufacturers with distribution data and customer feedback to support their PMS plans per MDR Article 83.

Person Responsible for Regulatory Compliance

Per MDR Article 15, the company has designated a Person Responsible for Regulatory Compliance (PRRC) within the organization. The PRRC ensures:

• Conformity of devices is appropriately checked before release for distribution
• Technical documentation from manufacturers is reviewed and verified
• Post-market surveillance obligations are met per MDR Articles 83 and 86
• Reporting obligations per MDR Articles 87 to 91 are fulfilled
• The declaration of conformity referred to in Article 19 has been drawn up

The PRRC role within Nordic Research Accessories AB is performed by the founder, with documented qualifications per MDR Article 15(1)(a) — a diploma, certificate, or other evidence of formal qualification in a relevant field, combined with at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Supplier qualification

All medical device suppliers must meet the following qualification criteria before being approved as a source of distribution:

1. Valid ISO 13485 certification. Manufacturer must hold current ISO 13485:2016 certification from an accredited certification body. Certificate is verified and recorded.
2. CE marking authority. Manufacturer has appropriate CE marking authorization, including notified body involvement where required for Class IIa or higher devices.
3. EU Declaration of Conformity. A valid, current EU Declaration of Conformity covering each SKU we distribute is on file.
4. Technical documentation availability. Manufacturer commits to providing technical documentation upon request from competent authorities, as required by MDR Article 10(3).
5. Vigilance cooperation. Manufacturer commits to participating in the vigilance system and accepting forwarded complaints per Article 14(5).
6. UDI assignment. Manufacturer has assigned UDI codes per MDR Article 27, with submission to EUDAMED database.

Suppliers are re-evaluated annually. The supplier qualification status is documented in the supplier register, with surveillance audits conducted as needed.

Nordic Research Accessories AB does not provide medical advice, treatment recommendations, or guidance on use of medical devices for clinical purposes. Users of distributed devices are responsible for determining suitability for their specific application and operating in accordance with manufacturer instructions for use.