Legal Regulations

ACF Medical meets all requirements for new Medical Device Regulation (MDR) EU 2017/745​

In order to take quick actions, preparations are finalized for the new regulation. All our documentations, needed evaluations and risk analyses are ready for the next years. Our EC certificate is renewed in 2019 and valid till 2024. Significant changes on production processes are made before implementation date of MDR (26 May 2021) and we do not predict any significant change at least 1 year for our products.

European Legislations

According to the legal obligations, we are supposed to comply with European Legislations.

Medical Device Directive (MDD) EU 93/42/EEC

Legal framework in Turkey relies on European Council Directives 90/385/EEC and 93/42/EEC and which entered into force on June 7, 2011. Legislations are fully adapted to the EU regulations.

According to the special agreement between European Union and Turkey, all medical devices manufactured in Turkey, should meet MDD as required by law.

Turkey has separated EU Medical Device Directive into 3 directives: Medical Devices Directive, Active Implantable Medical Devices Directive, In-Vitro Diagnostic Devices Directive.

Our competent authority is Turkey Medicines and Medical Devices Agency. All our reportings are made to the European Commission via our authority.

Medical Device Regulation (MDR) EU 2017/745

When the MDD came into law in 1992, medical devices were not various like present. With the new technologies, the sector has changed. Due to some diffuculties on devices such as disabilities on characterising devices, there was a need for a new legislation.

According to previous directive, EU members had to interpret and legalise the directive in compliance with their law. Member states now have to directly put into action this new regulation by translating to their legal system.

In May 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices “EU Regulation” entered into force with a transition period by May 2021.

A draft regulation has been prepared by Turkish Ministry of Health based on EU regulation and submitted to the Commission for approval.

ISO 13485 Quality Management System

ACF Medical meets all requirements for a better quality system. Our abilities can be seen on every single part of our company including design and development, production, storage and distribution, installation, or servicing of a medical device.

Key responsibilities are accounted for in our quality management system by monitoring, maintaining, and controlling the processes. Our factory is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations.

ISO 14971 standard, which is one of the referenced standards, has an important place in our quality system. The entire quality system is kept always up-to-date, based on the guidance documents, therefore, we can manage the risks effectively. In addition, the standard asks us to be more stringent when it comes to our outsourcing processes by put-ting into place controls, such as written agreements, for assessing our suppliers based on the risks.

Thanks to our ISO 13485 specialists who received training from the best consultants all over world, safe and effective medical devices are provided and customer and regulatory requirements fulfilled. We mainly focus on post-market activities, including customer complaint handling and regulatory reporting.

Device Registrations

We are proud of meeting all requirements of different countries

In order to offer to the citizens a good level of health system, countries wish to create their own regulatory systems by considering their patients’ safety. Goverments put in place policies that will address all elements related to medical devices, ranging from access to high quality, affordable products, through to their safe and appropriate use and disposal. Thus, medical devices which contain high risks for the patients when the appropriate conditions are not provided, are the key devices for the countries which manufacture or import them. It is clear that countries have different needs. Sometimes these needs should be responded via some different legislations.

States wish for companies that can trace their products in the field, have completed all risk analyzes of the device and have the highest quality and safety standards to sell products in their countries.

All countries who wish to implement improved medical device regulatory systems are encouraged by World Health Organization (WHO) who is reinforcing its role in providing technical supports.

With our exclusive distributors worldwide, our products have been registered in many countries.

Post Market Surveillance

ISO 13485 gives us an outline of a quality management system (QMS) structure which compels the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes for our medical devices.

Post-Market Surveillance has become crucial according to the new European Medical Device Regulation (MDR).

Our Method

We are trying to improve how we analyze failure trends thanks to our data analysis team. Our special software allow us to analyze complaint record data to identify trends and patterns that may represent opportunities to reduce or eliminate specific customer issues.

Our primary objectives are to summarize and prioritize the findings from field actions and projects showing anticipated benefits to customers. Post-Market team is leading deep cross-functional root cause investigations on potential product compliance issues and communicate outcomes across different functions and levels within our company.

With the risk management team, we drive updates to risk management documentation and risk management methodology to improve Post Market systems and processes.

We plan, prepare, review findings and discuss at quality data review (QDR) periodic meetings. One of our main goals is to finalise QDR activities owned by Failure Analysis Engineering (FAE) and other departments.