Navigating Article 16 of the MDR: How AF Pharma Can Support Your Business
The Medical Device Regulation (MDR) 2017/745 has introduced a series of stringent requirements for manufacturers, importers, distributors, and economic operators involved in the EU medical device market. One critical aspect often overlooked is Article 16, which addresses activities involving the rebranding, repackaging, or relabeling of medical devices. Non-compliance with this article can lead to significant regulatory hurdles and legal risks.
At AF Pharma, we specialize in regulatory compliance for medical devices and can guide you through the complexities of Article 16 to ensure your business operations are fully compliant.
What Does Article 16 of the MDR Cover?
Article 16 regulates activities performed by entities other than the original manufacturer, such as:
Repackaging or Relabeling: When a distributor or importer changes the packaging or labels of a device to market it under their own name.
Translation of Information: Altering the instructions for use (IFU) or translating the labeling.
Modifications That May Affect Compliance: Any change to the device or packaging that might impact the device's conformity with the MDR.
Under Article 16, any economic operator performing these activities must:
Inform the manufacturer and competent authority of their intentions in advance.
Ensure the modifications do not affect the original conformity of the device.
Implement a quality management system (QMS) to verify compliance.
Notify and cooperate with the relevant notified body, if applicable.
Challenges of Article 16 Compliance
Complying with Article 16 requires not only technical expertise but also a robust documentation process and communication with multiple stakeholders, including the manufacturer, notified bodies, and competent authorities. Failing to meet these requirements can result in delays in product placement, withdrawal from the market, or significant financial penalties.
How AF Pharma Can Help
As a trusted regulatory specialist with deep expertise in the EU, UK, US, and Australian markets, AF Pharma offers comprehensive support to help you comply with Article 16. Here’s how we can assist:
Regulatory Assessment
Determine whether your activities fall under Article 16.
Conduct gap analyses to identify compliance issues.
Document Preparation and Review
Assist in preparing notifications to the manufacturer and competent authority.
Review translated or updated labeling and IFU for regulatory compliance.
Quality Management System Implementation
Develop or enhance your QMS to meet MDR requirements.
Provide training and resources for your team.
Notified Body Liaison
Facilitate communications with notified bodies to streamline conformity assessments.
Ongoing Support
Monitor regulatory updates to keep your operations compliant.
Act as your regulatory partner in navigating complex challenges.
Why Choose AF Pharma?
With a proven track record in medical devices, cosmetics, and dietary supplements across multiple markets, AF Pharma combines global expertise with personalized service. Based in Spain, we also act as an EU Rep, offering unparalleled support for companies targeting both European and international markets.
Let us help you navigate the intricacies of Article 16 and ensure your operations align with the MDR. Contact AF Pharma today to discuss how we can support your regulatory needs.
Stay compliant. Stay ahead. AF Pharma is your regulatory partner every step of the way.
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