Welcome to our website! Here you will find templates for DIN EN ISO 13485, 14971 & MDR 2017/745 for your certification or product approval!
Here you will find an overview of templates that meet the requirements of DIN EN ISO 13485, 14971 and in conjunction with MDR 2017/745. We also have a template for a product file in accordance with the MDR. You can find detailed information on the individual products by clicking on the desired product.

DIN EN ISO 13485, DIN EN ISO 14971 and MDR 2017/745. Here are our templates.

QM template according to DIN EN ISO 13485:2021 in compliance with MDR 2017/745 requirements

QM manual according to DIN EN ISO 13485:2021 | Trade and import of medical devices

QM system according to DIN EN ISO 13485:2021 DIN ISO | Medical device production, service without MDR

MDR 2017/745 | Technical documentation

Risk management acts according to DIN EN ISO 14971:2022 | Risk management for medical devices

Why are the templates necessary?

A company requires a quality management system in accordance with ISO 13485 and technical documentation in accordance with MDR 2017/745, including risk management, if it develops, manufactures or distributes medical devices in the European Union.

There are different requirements depending on the role of the company (e.g. manufacturer, importer, distributor, contract manufacturer) and the risk class of the product. I will now explain the relationships and obligations in detail.

Quality management system according to ISO 13485 – When is it required?

ISO 13485 is an internationally recognized standard for quality management systems specifically for medical devices. It ensures that a company is able to develop, manufacture and distribute medical devices safely and in compliance with regulatory requirements.

1.1 Who needs ISO 13485?

A quality management system in accordance with ISO 13485 is required or strongly recommended in the following cases:

Medical device manufacturer

Companies that develop and produce medical devices must have a QM system certified in accordance with ISO 13485 if their product falls into classes IIa, IIb or III.
Certification is not mandatory for Class I, but is nevertheless advisable, especially if sterile or metrological products (Class Is or Im) are involved.

Supplier and service provider for medical device manufacturers

Companies that provide components or services to medical device manufacturers are often contractually obliged to comply with ISO 13485, especially if their products have a direct impact on safety or quality.

Contract manufacturer and OEM manufacturer

Companies that manufacture medical devices for third parties must also implement a QM system in accordance with ISO 13485.

Sterilization service provider

If a company offers sterilization processes for medical devices, it must operate an ISO 13485-compliant QM system.

EU Authorized Representatives

Companies that act as EU representatives for non-EU manufacturers generally also need an ISO 13485-compliant system to ensure regulatory requirements are met.

1.2 Why is ISO 13485 important?

ISO 13485 is often a basic requirement for obtaining certification in accordance with MDR 2017/745. Companies must prove that their quality management system meets the regulatory requirements. Without a structured QM system, a manufacturer cannot obtain a CE certificate for its medical devices.

Technical documentation according to MDR 2017/745 – When is it required?

The MDR (Medical Device Regulation, 2017/745) requires manufacturers to create complete technical documentation for every medical device. This documentation serves as proof that the product is safe, efficient and MDR-compliant.

2.1 Who has to create technical documentation?

Every company that distributes medical devices within the EU must keep technical documentation in accordance with the MDR. This concerns:

Manufacturers of medical devices of any risk class.
Importers who import medical devices from third countries into the EU.
distributors if they market a product under their own name (“private label”).

2.2 Content of the technical documentation

The technical documentation must contain all evidence that the medical device meets the essential safety and performance requirements in accordance with MDR Annex I.

A typical structure of technical documentation includes

Product description & specifications

Technical features, construction drawings, packaging.

Classification of the medical device

According to MDR (Class I, IIa, IIb, III).

Risk management acts according to ISO 14971

Identification and assessment of all potential risks over the entire life cycle.

Clinical evaluation & performance tests

Studies, tests and evaluations on safety and performance.

Validation and verification

Testing of materials, software, biocompatibility, sterility, electrical safety, etc.

Instructions for use & labeling

Compliant with MDR specifications for labels, IFU (Instructions for Use).

Post-Market Surveillance (PMS) & Vigilance

Monitoring of products after they have been placed on the market, reporting of incidents.

No medical device may be CE-certified and sold in the EU without complete technical documentation.

Risk management according to ISO 14971 – Why is it important?

Risk management is a central component of the MDR and must be included in the technical documentation. ISO 14971 describes the risk management requirements for medical devices.

3.1 Who must carry out risk management in accordance with ISO 14971?

All manufacturers of medical devices, regardless of the risk class.
Suppliers if their components or services are relevant to safety.

3.2 What does risk management involve?

Risk management includes

Identification of risks

What dangers could arise from the product?

Assessment of risks

Determine probabilities and severity of risks.

Risk control measures

Design changes, protective mechanisms or warnings to minimize risks.

Verification of the measures

Check whether the measures actually reduce the risk.

Post-market surveillance

Recognize new risks during use and take measures.

A medical device cannot be approved without documented risk management.

Summary:

A QM system in accordance with ISO 13485 is almost always required for medical device manufacturers.
Technical documentation according to MDR is mandatory for every medical device.
Risk management in accordance with ISO 14971 must be included in the technical documentation.