Medical Device Regulation (MDR)

The time required to obtain a CE mark for medical devices varies based on factors such as device classification, chosen conformity assessment route, preparation of documentation, Notified Body involvement, regulatory changes, manufacturer’s experience, timeliness of communication, availabilty, et cetera.

Generally, the process can takes up to a year, ranging from several months for Class I devices to over a year for devices requiring Notified Body assessment. Manufacturers should initiate the process well in advance to account for potential delays and ensure a smooth certification process.

If your product falls within the scope of the Medical Device Regulation 2017/745, CE marking is mandatory. With the MDR, the rules have been tightened, and as a result, more products will fall under this regulation. If your medical device was certified under the Medical Devices Directive 93/42/EEC (MDD), there is a high likelihood that you will need to be recertified under the Medical Devices Regulation 2017/745 (MDR).

If it does not fall within this scope, you will have to check if there are any other relevant CE directives concerning your device. If this is the case, CE marking is mandatory as well; if not, it is even prohibited to apply CE marking to your product.

In the context of EU MDR compliance, ISO 13485 certification is not a mandatory requirement. While the EU MDR law does not explicitly mention ISO 13485, it does mandate the implementation of a Quality Management System (QMS). The EU has outlined a set of harmonised standards to guide companies in understanding applicable standards for medical devices in the EU. Notably, ISO 13485:2016 is the sole QMS standard listed, making it kind of mandatory for medical device Class IIA, IIB and III.

Classifying your product is an essential part of obtaining the CE mark. Medical device classes refer to the categorisation of medical devices based on their level of risk and the regulatory controls necessary to ensure their safety and effectiveness. In the European Union, medical devices are classified into Class I (Is, Im, Ir), Class IIa, Class IIb and Class III, based on the risk associated with their use. The classification is typically based on factors such as the intended use, duration of contact with the body, and potential risks associated with the medical device. Manufacturers must adhere to specific regulatory requirements based on the assigned class to ensure patient safety and device effectiveness.

Class I

• Defintion: Medical devices with low risk
• Examples: glasses, sports tape

Class Is

• Definition: Sterile medical devices with low risk
• Examples: sterile disposable syringes

Class Im

• Definition: Medical devices with low risk for measurement
• Examples: clinical thermometers, droppers, non-invasive blood pressure monitors

Class Ir

• Definition: Reusable non-invasive surgical medical devices with low risk
• Examples: non-invasive instruments like clamps, clips, drills, scissors, saws

Class IIa

• Definition: Medical devices with medium risk
• Examples: trainers for pelvic floor muscles, most Medical Device Software (MDSW)

Class IIb

• Definition: Medical devices with medium to high risk
• Examples: blood bags, urethral stents, dental implants, penile implants

Class III

• Definition: Medical devices with high risk
• Examples: prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expanders

A Notified Body (NoBo) is an organisation that is designated by a European country to assess the conformity of certain products and devices, such as medical devices, before being placed on the market. Notified Bodies play a crucial role in the regulatory processes for various products, including medical devices, as well as other sectors such as machinery, personal protective equipment, and more. These bodies carry out tasks that are related to conformity assessment procedures set out in the applicable legislation when a third party is necessary.

Notified Bodies operate independently and are designated by EU member states’ competent authorities. The European Commission maintains a comprehensive list of Notified Bodies, and each Notified Body is assigned a unique identification number. The designation process involves demonstrating the competence and impartiality of the organization.

It’s important to note that the involvement of Notified Bodies is specific to certain regulatory frameworks, such as the Medical Device Regulation (MDR) in the EU. The specific requirements and procedures can vary based on the type of product and the applicable regulations.

A Risk Management System for medical devices is a structured and systematic approach to identifying, assessing, controlling, and monitoring risks associated with the entire lifecycle of medical devices. Guided by standards like ISO 14971, it involves the systematic identification of potential hazards, evaluation of risks, implementation of control measures, clear communication about risks, ongoing monitoring, comprehensive documentation, and integration with Quality Management Systems. The objective is to proactively manage risks to ensure the safety and performance of medical devices, meeting regulatory requirements and addressing potential concerns throughout the product lifecycle.

The EU MDR is a regulation which is mandated by the European Union that dictates what needs to be done by a company that wants to manufacture or import medical devices into the European Union. The mandate provides information on how medical devices need to be marked and in conformity with regulations, along with updates on what information needs to be submitted to the updated Eudamed database, which stores regulatory information for each medical device. ISO 13485 is an internationally recognised standard for creating a Quality Management System for medical device companies anywhere in the world. Using ISO 13485 as a standard will enable any organisation to illustrate that their products meet customer and regulatory requirements.

The difference between medical devices and medical software lies in their nature and function. Medical devices refer to physical, hardware-based devices used for medical purposes, such as imaging equipment, surgical instruments, or monitoring devices. On the other hand, medical software refers to programs and codes designed to perform specific medical functions, such as pacemaker software or mobile health apps that provide medical advice on metrics like blood pressure, glucose levels, or heart rate. In short, medical devices are tangible physical items, while medical software consists of digital programs used for medical purposes.