Regulatory Compliance

• It is a detailed derivative of the Medical Device Directive (MDD). The transition from 3 Directives to 2 Regulations. The new European Medical Device Regulation (MDR) with many of its new rules is a challenge for all involved.
• European Medical Device Regulation (MDR) went into force in May 2017. It replaces the existing Medical Device Directive (MDD) with a grace period till May 2024.
• The objective of these changes is mainly to strengthen the regulatory requirements across the European Union.

OUR MDR REGULATION JOURNEY

• Durrani & Co. is preparing and fulfilling new requirements and has already applied to Notified Body UDEM (Notified Body # 2696).
• The MDR transition program has been in place at Durrani & Co. since May 2021, to ensure compliance with the MDR regulations.
• Durrani & Co. is using the grace period till May 2024 to its advantage and working day and night to make the transition easier for themselves as well as for their valued business partners.
• Various initiatives have been undertaken and implemented to ensure the smooth transfer from MDD to MDR.

Frequently Asked Questions (FAQ)

To what extent is Durrani & Co. affected by MDR?

• Since the Year 1972, as a manufacturer of surgical instruments, Durrani & Co. has been complying with mandatory standards as and when necessary.
• Different work groups within the company are updating the technical documentation and revising processes in order to ensure they are MDR compliant.
• Furthermore, Durrani & Co. is obliged to provide product information, including unique device identification data (UDI), as well as post-market surveillance information, etc. to EUDAMED.

How is Durrani & Co. Implementing MDR Requirements?

Durrani & Co. has already enforced comprehensive measures and assigned human and financial resources to ensure the on-schedule implementation of the MDR.

How Durrani & Co. plans to implement the MDR requirements within its Quality Management System?

The quality management systems of Durrani & Co. have already been certified in accordance with ISO 13485. MDR-compliant technical documentation for our products is already in progress. The product transition to MDR will take place before the closure of the grace period in May 2024.

Will all products of Durrani & Co. be certified to MDR?

• Generally speaking, Yes! – depending on the planned lifecycle, the products are being certified according to MDR.
• As in previous years, Durrani & Co. will continue to make adjustments to its product portfolio.
• New products will be added to the portfolio and older generations will be replaced, outdated products will be removed from the product portfolio.
• As part of our regular assortment management process, we will continue to communicate corresponding product assortment changes in a timely, open, transparent and targeted manner to the respective customers affected and offer alternatives where possible.
• Durrani & Co. is using the MDR transition period in which we will transfer our product portfolio to MDR within the allowed grace period.
• During this transition period, Durrani & Co. will place both MDD and MDR-certified products on the market.

How can Durrani & Co.`s customers receive a Declaration of Conformity (DOC) and Instruction for Use?

• Durrani & Co. is actively supporting all our customers in obtaining information. Declarations of Conformity (DOC) and Instruction for Use (IFU) are made successively available digitally since May 2021.
• Declarations of conformity (DOC) can be obtained easily, For technical reasons, Durrani & Co. will only be able to make the DOC for the products in our offered range with exceptions as applicable.
• Instructions for use (IFU) is also available with the article number/Product Code.

Durrani & Co.’s Certifications since 2001;

ISO 9001           ISO 13402

ISO 13485         ISO 7153-1

ISO 7741           CE MDD

• We have also successfully implemented UDI-DI, registration on EUDAMED, and upgradation/preparation of Technical documentation, etc. is in progress as per MDR requirements.
• As planned, Durrani & Co. will become MDR compliant within the next year as per the classification of medical devices in order to remain on the market even after 2024 when it takes effect.