This document is a formal notification from a Notified Body (NB) designated under Regulation (EU) 2017/746 (IVDR). The confirmatiom letter is the receipt of a formal application and the conclusion of a written agreement with a medical device manufacturer, as per Annex VII of the IVDR.
Key Points of the confirmation letter
Notified Body Confirmation:
- The letter confirms that the NB has received and accepted a formal application from a medical device manufacturer.
- A written agreement has been signed, fulfilling regulatory requirements under IVDR.
Device Surveillance and Certification:
- The letter lists devices for which the NB is responsible for appropriate surveillance under Directive 98/79/EC (IVDD).
- It also lists devices that, while having a formal application and agreement under IVDR, are not yet under NB surveillance as per IVDD.
Transitional Provisions:
- Devices previously certified under IVDD that expired between 26 May 2022 and 9 July 2024 are addressed.
- The letter ensures that these devices have signed agreements under IVDR before IVDD certificate expiry or have obtained necessary derogations or exemptions.
Transition Timelines:
- For devices under IVDD transitioning to IVDR, compliance timelines are specified:
- Class D devices: until 31 December 2027.
- Class C devices: until 31 December 2028.
- Class B and sterile Class A devices: until 31 December 2029.
Device Listings:
- The letter includes tables categorizing devices under surveillance and those not yet under NB surveillance, with details such as device names, classifications, and corresponding IVDD references.
This document is essential for ensuring regulatory compliance and smooth market transition for medical device manufacturers under evolving EU regulations.
AF Pharma
In the ever-evolving landscape of medical device regulations, ensuring compliance with EU regulations is crucial for manufacturers looking to enter or remain in the European market. AF Pharma, as an EU Authorized Representative, provides indispensable support to medical device manufacturers, helping them navigate complex regulatory frameworks and maintain market access.
What is an EU Authorized Representative?
An EU Authorized Representative is a person or company based in the European Union that acts on behalf of a non-EU manufacturer in carrying out certain tasks required under the EU regulations. These tasks include ensuring that the medical devices meet the necessary requirements and that the required technical documentation is available for inspection by the regulatory authorities.
AF Pharma's Role
As an EU Authorized Representative, AF Pharma offers a comprehensive suite of services tailored to meet the specific needs of medical device manufacturers:
Regulatory Compliance: AF Pharma ensures that manufacturers comply with the Medical Device Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. These regulations set high standards of safety and performance for medical devices and in vitro diagnostic devices, respectively.
Technical Documentation and Filing: AF Pharma assists in the preparation and maintenance of the technical documentation required for CE marking. This includes the risk management file, clinical evaluation report, and other essential documents that demonstrate compliance with the applicable regulatory requirements.
Liaison with Notified Bodies:AF Pharma coordinates with Notified Bodies, which are organizations designated by EU member states to assess the conformity of certain products before being placed on the market. This involves managing applications, agreements, and surveillance activities as per the IVDR and MDR requirements.
Market Surveillance and Vigilance: AF Pharma monitors the performance of medical devices on the market, reporting incidents and coordinating recalls if necessary. This proactive approach ensures ongoing compliance and patient safety.
Labeling and Instructions for Use: Ensuring that medical device labeling and instructions for use meet the regulatory requirements is crucial. AF Pharma reviews and approves these materials to ensure they are accurate, clear, and compliant.
Conclusion
Navigating the EU regulatory landscape can be daunting for medical device manufacturers. However, with AF Pharma as an EU Authorized Representative, manufacturers can confidently ensure compliance, secure CE marking, and maintain market access. By leveraging AF Pharma's expertise and comprehensive services, manufacturers can focus on what they do best – innovating and delivering high-quality medical devices to improve patient care.
For more information on how AF Pharma can support your regulatory needs, contact us today. Your compliance is our commitment.
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