Medical Device Regulation in Turkey: A Guide for Manufacturers, Importers and Distributors

Medical Device Regulation in Turkey: What You Need to Know

The medical device sector in Turkey underwent a fundamental transformation with the Medical Device Regulation published in Official Gazette No. 31499 (repeated issue) of 2 June 2021. Drafted in line with the EU Medical Device Regulation (EU) 2017/745 (MDR), it introduced new and extensive obligations for the economic operators in the sector: manufacturers, importers and distributors.

This article examines the scope of the Regulation, the obligations it imposes and the legal consequences of non-compliance from a corporate perspective.

Overview of the Turkish Medical Device Regulation

The Regulation has four key elements:

• it assigns separate responsibilities to manufacturers, importers and distributors,
• it classifies devices according to their risk level,
• it sets strict standards for design, manufacturing, labelling and clinical evaluation,
• it attaches administrative and legal sanctions to non-compliance with these standards.

Achieving compliance within this complex regulatory framework is a process that calls for legal support for every business in the sector.

Scope of the Regulation

The Medical Device Regulation covers medical devices intended for human use that are placed on the Turkish market, together with their accessories.

In vitro diagnostic medical devices are governed by a separate instrument published on the same date: the In Vitro Diagnostic Medical Device Regulation.

Fundamental Principles of the Regulation

The Regulation governs the entire lifecycle of medical devices:

• manufacturing,
• importation,
• certification and conformity assessment,
• distribution and marketing.

Its aim is to raise product safety, performance and quality while protecting the safety of patients and healthcare professionals.

Responsibilities of Manufacturers and Importers

The Regulation sets out detailed responsibilities for manufacturers and importers.

Manufacturers must:

• document the conformity of their products,
• prepare the technical documentation,
• complete the necessary tests and evaluations.

Importers are responsible for ensuring that the products they place on the market comply with legal requirements.

Distributors must also verify conformity when making a device available on the market. For this reason, the allocation of responsibility in distribution agreements must be structured carefully.

Risk Classification

Medical devices are divided into four risk classes based on the potential harm they may cause to patients, users or other persons:

• Class I: Low risk
• Class IIa: Moderate risk
• Class IIb: High risk
• Class III: Very high risk

A device’s class directly determines the applicable conformity assessment procedure and the extent of notified body involvement.

Requirements of the Regulation

The Regulation imposes the following core obligations on manufacturers:

• Design and development: Devices must be designed and developed in a safe and effective manner.
• Manufacturing: Production must take place under control and within a compliant quality management system.
• Labelling and packaging: Devices must be labelled and packaged clearly and accurately.
• Clinical evaluation: The safety and effectiveness of the device must be demonstrated through clinical evaluation.
• Post-market surveillance: The safety and effectiveness of devices on the market must be monitored continuously.

Distribution and Marketing Principles

The Regulation contains specific principles for the proper distribution and marketing of medical devices. In this context, compliance with the rules on the promotion, advertising and sale of medical devices is essential.

For companies active in the EU market, certification requirements based on CE marking and standards such as ISO 13485 are also important.

Penalties for Non-Compliance

Economic operators that fail to comply with the Regulation may face a range of sanctions under the Product Safety and Technical Regulations Law No. 7223:

• a requirement to remedy the non-conformity,
• administrative fines,
• suspension or withdrawal of certificates,
• a ban on placing the device on the market,
• recall of the device.

Law No. 7223 provides that no administrative sanction is imposed on an operator that fully remedies a non-conformity on its own initiative, before any request by the competent authority (Art. 21). This provision clearly shows the legal value of a proactive compliance and recall strategy.

Current Challenges and Solutions in the Industry

The Regulation has brought certain structural challenges for the sector:

• limited notified body capacity,
• more demanding clinical evaluation and technical documentation requirements,
• post-market surveillance obligations that require continuous resources.

The main solutions to these challenges are:

• early planning of the certification process,
• a clear allocation of compliance obligations in supply and distribution agreements,
• documentation of internal compliance processes.

The Medical Device Regulation is a complex instrument. Manufacturers must fully understand its requirements to ensure that their devices are compliant.

The Medical Device Regulation and Legal Implications

Non-compliance with the Regulation creates more than a risk of administrative sanctions.

Under Law No. 7223, where a product causes harm to a person or property, the manufacturer or importer must compensate that harm (Art. 6). Where more than one party is responsible, liability is joint and several. Contractual provisions that exclude or limit this liability are void.

For this reason, compliance processes also form the foundation of a company’s defence in product liability claims. Recourse relationships within the supply chain should likewise be structured from the outset.

Support from istlegal Attorneys at Law

Medical device companies operating in Turkey may benefit from legal advice on compliance with the Medical Device Regulation and on potential disputes. These companies include manufacturers, importers, distributors and licence holders.

At the intersection of product liability and medical device legislation, istlegal Attorneys at Law provides legal advice and litigation services to companies on meeting the Regulation’s requirements, ensuring device compliance and defending their rights in disputes concerning medical devices.