Overview:
The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements.
Introduction:
The European Medicines Agency (EMA) defines medical devices as products or equipment intended generally for a medical use and are regulated at Member State level. In the EU, Medical Devices have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
The MDR Regulation
The current Regulation governing Medical Devices is the Regulation (EU) 2017/745 on Medical Devices (MDR), that has been in force since May 2017, but is in a transitional period, until May 26, 2021.
The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements. Regardless of the class, technical documentation is mandatory for all medical devices. Requirements regarding the technical documentation are covered in Annex 2 and Annex 3 of the MDR.
Each chapter provides a set of requirements for medical device manufacturers to follow, which are described below.
Section 1:
- Introduction of the device. The goal is to fully understand what the product is like, to describe how the product works, the intended use, whether there are any warnings or precautions, and the contraindications.
- It is necessary to explain the system of assigning the basic UDI-DI and UDI-DI, and to describe how the product is classified (Annex 8), and how the product is classified (Annex 51).
Section 2:
- The information on the labels and instructions for use (IFU) must be in accordance with what you stated in the previous chapter.
- If the product is certified according to the Medical Device Directive (MDD), more information (symbols) needs to be put on the label.
Section 3:
- All documents that followed the product development (procedures, research plans, protocols, results of verification and validation).
- Description of the production process. Also, all other companies involved in the production of the product in any way (such as sterilisation, production of a particular part or accessory, or packaging) should be described as well.
Section 4:
- The purpose of this section is to provide evidence that the product is designed and manufactured in accordance with all applicable requirements, in order to ensure its safe use and effectiveness.
- When a requirement is not applicable, a statement must be made as “NA” or “NO“ in the checklist. Additionally, it is necessary to provide clear justification as to why the requirement is not applicable.
Section 5:
- It is necessary to have a risk management procedure, that is, a risk assessment for the entire life cycle of the product (from design, entry of raw materials into the warehouse, through the production itself to the use of the product by the patient or user and disposal).
- The next step is to introduce various measures to minimise these risks and keep them at that level.
Section 6:
- This section covers all the tests on the product to prove its safety and performance (biocompatibility, safety regarding chemical components, electricity safety, sterility, usability, clinical investigation, etc).
Technical Documentation for Post-Market Surveillance
The monitoring performance in the post-market phase is crucial for the identification of risks during practical product use. The post-market surveillance (PMS) system requires manufacturers to continuously and systematically monitor products to ensure that there are no malfunctions or undetected safety issues. The post-market surveillance (PMS) system is covered in Appendix III of the MDR.
The post-market surveillance system includes the following documents:
- PMS Procedure,
- PMS Plan and PMS Report (for all class I medical devices), or
- Periodic Safety Update Report (for classes IIa, IIb and III).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.