Understanding the Medtech Regulatory Process in Europe

In Europe, the medical device market is very large and advanced. To launch a new medical device in Europe, you must satisfy a data set of various European laws that have been designed to assure that patients are safe, that products work well and are of high quality. For all entrepreneurs who want to sell medical devices in Europe, it is crucial that they understand the legal landscape for successful entry into the market and long-term success.

Europe’s medical devices are regulated mainly by two key regulations:

• Medical Device Regulation (MDR) 2017/745: This regulation covers any medical device, from a tool used to diagnose a patient to a tool used to perform surgery on a patient.
• In Vitro Diagnostic Regulation (IVDR) 2017/746: This regulation applies to all in vitro diagnostic devices, such as blood tests and laboratory equipment.

These two regulations have replaced the prior set of regulations and require more rigorous safety, clinical evaluation, and transparency for products in the global medical device marketplace.

Classification of Medical Devices

In Europe, medical devices are classified according to their risk type, their use target, and how they will affect the patients in the country of sale:

• Class I are low-risk devices (the most common examples include bandages and non-invasive tools).
• IIa/IIb are medium-risk devices (the most common examples include infusion pumps and diagnostic-type equipment).
• III are high-risk devices (the most common examples include cardiac devices and life-support equipment).

The level of classification of the medical device will determine which regulatory path the manufacturer follows (to market it), what documentation the manufacturer must provide, and whether they must use a Notified Body as part of the process.

Notified Bodies Help with Medical Device Approval

Notified Bodies are independent organizations appointed by the EU member states to assess conformity with the regulatory requirements for a medical device. Responsibilities include the following:

• Conducting audits and reviewing technical files.
• Reviewing clinical evidence and risk management plans.
• Issuing CE Certificates that must be acquired by the manufacturer prior to being able to bring the medical device to market.

For higher-risk medical devices (Class IIb and III), the manufacturer must involve a Notified Body before the product is permitted to be marketed.

Evidence and Clinical Assessment

• A robust clinical assessment is essential for compliance with European medtech regulations. Manufacturers must demonstrate the safety, performance, and clinical benefit of their devices.
• Clinical evidence can be collected in a number of ways, from pre-existing studies and literature to new clinical research.
• Once the clinical evidence is collected, a risk assessment will need to be conducted to identify and manage any potential hazards related to the device, and to provide appropriate risk mitigation strategies.

As part of ongoing compliance, clinical evidence should be continuously updated throughout the duration of the device’s life cycle.

Technical documentation 

It is to be retained by each manufacturer in order to provide evidence of conformance. It includes:

• A description of the device and its intended use,
• Design and manufacturing information,
• Risk management reports, clinical evaluation and post-market surveillance plans.

The technical documentation is reviewed by Notified Bodies, or by the competent authorities as part of the conformity assessment process.

Post-market surveillance (PMS) and vigilance 

It demonstrates that the manufacturer has an obligation to monitor the continued performance and safety of their devices in the marketplace after they have received CE marking. This includes:

• Continually monitoring adverse events and complaints;
• Notifying regulatory authorities of any serious incident; and
• Updating the manufacturer’s risk management and clinical evaluation based on data collected from the real world.

PMS and vigilance is an important way for manufacturers to continue to demonstrate conformance, to ensure ongoing protection of patients, and to maintain trust in their own brand.

Challenges for Entrepreneurs in Medical Technology

• Creating and maintaining complex documentation: Preparing the necessary clinical, technical & quality documents required by regulatory bodies can take a long time & be very expensive. 
• Timeliness of the process: The time required for regulatory assessments, especially those associated with high-risk medical devices, may be several months or even years.
• Changes to regulations: It’s important to stay up-to-date with the Medical Device Regulation (MDR), the In-Vitro Device Regulation (IVDR), and new guidelines released by European Union authorities to ensure compliance.

It is essential for entrepreneurs to fully understand the Entire European MedTech regulatory process before entering this fast-growing & innovative healthcare industry. By understanding the MedTech Classification system and the Notified Body process for generating a clinical evaluation or Post Market Surveillance Plan, you will identify the associated regulatory process for each of these activities and ensure the safety of your customers & establish a successful commercial market entry for your new product.

Life Science Market Research offers assistance with identifying current regulatory trends, conducting market research, preparing market analyses, and providing additional advice in this area to assist Medtech startup companies.