The Medical Device Coordination Group plays a central role in the medical device regulatory landscape in the European Union. Therefore, it is of crucial importance to everyone in the medical industry to be informed about the group’s work and the latest guidance updates.
As an experienced CRO based in the EU, ECLEVAR understands the importance of ensuring regulatory compliance. Read this comprehensive guide to understand what the Medical Device Coordination Group is, why it is important to know their guidelines and how your company can stay compliant.
What You Will Learn in This Article:
- What is MDCG?
- Why it is important to know their requirements and guidance
- Best practices to navigate the guidelines
- Benefits of following the coordination group’s guidance
- Future developments on guidelines
- How ECLEVAR can help your company to stay compliant
What is MDCG?
The Medical Device Coordination Group is a group of experts created by the European Commission to deal with “key issues from the medical devices sector”. It is subdivided into 13 subgroups, each one providing guidance on a specific field. The members of the subgroups are chosen by EU Member States every 3 years, and they meet regularly with the EU Commission.
The group works to provide guidance on the interpretation and implementation of medical device regulations within the EU. This group also makes guidelines and documents available to help manufacturers ensure compliance with the EU regulatory framework.
Stakeholders such as medical device manufacturers, patients, European associations and healthcare professionals also participate regularly in the group’s meetings and give their input. The resulting guidance documents are a comprehensive evaluation of the best practices towards compliance with medical device regulations in the EU.
Why it is Important to Know MDCG Requirements and Guidance
The main purpose of the requirements established by the group is to ensure that all medical devices available on the European market are safe and serve their intended use. Therefore, complying with these requirements is, ultimately, a matter of public health. The regulatory framework guides all medical device manufacturers operating in the European Union and all other relevant players in the European medical device industry.
The European group not only provides the regulatory framework, but also a very comprehensive set of instructions and specific guidance on various aspects of medical device regulation, such as clinical trials, conformity assessments and labeling. Manufacturers can resort to this documented guidance to better understand, interpret and implement the regulatory requirements. These are some examples of the kind of guidance on requirements that the group provides:
- Guidance on the implementation of a quality management system
- Guidance on clinical evaluation requirements and processes
- Guidance on the requirements and processes for conformity assessment
- Guidance on post-market surveillance requirements and processes
As you can see, this guidance covers all stages of medical device development and selling. Non-compliance with the requirements they address can result in many serious consequences, such as:
- Product recalls
- Fines
- Legal action
- Impact on safety and efficacy of medical devices
- Delays in accessing the market (within the EU and beyond)
- Reputational damage to the company
- Loss of consumer confidence
Regulations are also constantly changing to the benefit and safety of patients. Keeping updated with the last additions to the guidance package is part of the strategy to stay competitive in the medical device market.
After years of experience in the EU medical device industry, ECLEVAR has built second to none expertise in regulations and our experts are always up to date with the latest guidance documents issued by the group. Explore the last section of this article to know how ECLEVAR can help you stay compliant in the EU as a medical device manufacturer.
Best Practices to Navigate Guidelines
As demonstrated above, understanding and following the guidance offered by the Medical Device Coordination Group is the best way to stay compliant with medical devices regulations in the European Union and safeguard patient’s safety, as well as avoiding fines and legal action and protecting the company’s reputation. Here we explore some best practices to stay updated on guidelines, understand and implement them.
Stay Informed
The MDCG website is always updated with the latest news and changes in regulations. Be sure to regularly check their webpage and any new document that is uploaded. There are other channels through which the group shares information, such as public consultations and newsletters. They are also good sources you can regularly check to stay updated on the latest guidelines developments.
Attending medical industry events such as seminars, conferences and workshops is also a good practice to increase your awareness of the latest regulatory changes. By joining manufacturers associations and groups, you can build a network of people with the same interests and concerns and have immediate access to valuable insights.
Implementing the Guidelines in Your Compliance Management System
A compliance management system is a record of the policies and procedures your company follows to ensure ongoing regulatory compliance. It is a good way to systematize compliance within your company and can simplify the process for everyone involved. Incorporating expert guidelines among the resources available in your compliance management system is a way to ensure that everyone in your organization that is involved with the product’s development is aware of the guidance available.
Regulatory affairs personnel, product development teams, and quality assurance professionals are some of the people who might benefit from having access to such guidance documents and help implementing the requirements, minimizing the risk of non-compliance issues and increasing the chances of having a smooth approval process. Your teams should also be engaged in regularly reviewing regulations, as they are dynamic and always changing, and revising the compliance management system to include the latest updates.
Engaging in MDCG Consultations
The Medical Device Coordination Group encourages interested parties and stakeholders in the medical device industry to engage in their consultation process. This is an excellent opportunity to not just be aware of the guidelines, but also get involved in their development. Industry professionals, patient representatives and various other stakeholders from the medical field, regardless of their location or organization, can take part in the group’s consultations.
Interested parties can apply to dedicated calls for expression of interest that usually open before guidelines and documents are finalized. Be sure to regularly check MDCG publications to know when interested parties may apply to take part in one of the group’s consultations. Feedback from the industry helps the European group to consider the needs of different stakeholders and adapt the guidance documents.
Benefits of Following MDCG Guidance
Now that you already know why it is important to stay updated with the current guidelines and how they can help your company to stay compliant, let’s wrap up the topic with a list of benefits of following this guidance. As a compliant medical device manufacturer, your company may:
- Benefit from streamlined regulatory processes, since following guidance can help simplify and speed up the regulatory approval process. Medical devices can be ready to be marketed in a shorter time.
- Improve the quality of products, because the guidelines are designed to ensure that medical devices are safe and effective. Manufacturers can improve the quality and reliability of their products when they adhere to requirements.
- Increase the company’s market access, since many countries recognize the expertise of the European group and use compliance with their guidelines as a condition to enter their markets.
- Contribute to the overall improvement of public health and healthcare systems by demonstrating commitment to patient safety.
[Future Guideline Developments
As already emphasized earlier, guidelines and requirements are constantly evolving, and it is important to stay informed about these changes to ensure regular compliance. The regulatory landscape responds to technology evolutions, new market trends, and patients’ feedback on safety and effectiveness of products. Therefore, it is possible to anticipate some developments that we may see in the near future and be ready to adapt regulatory compliance strategies.
It is very likely that concerns about cybersecurity will influence the next changes in medical devices regulations. As they become more connected and digitalized, it is natural that patients and healthcare providers want to be protected from hacking, leaking of private data and other cyber threats. The Medical Device Coordination Group will probably consider such concerns and focus some of the next additions to their guidelines on ensuring data privacy and patient’s digital safety.
We might also expect further standardization of medical device terminology. Manufacturers still have relative freedom in labeling and classifying products, which can be confusing for patients and healthcare providers. We will probably see new labeling and classification systems for medical devices that should be more closely observed to the benefit of users.
How ECLEVAR Can Help Your Company to Stay Compliant
As a CRO team of experts based in the EU, ECLEVAR understands the importance of the MDCG within the European regulatory landscape for medical devices. Guidelines are designed to help manufacturers to be compliant with all relevant regulations and safeguard patients’ safety, but because of the constant changes in such regulations, staying compliant can be a challenge.
Smaller companies with less resources can face even more difficulties when navigating medical device regulations and interpreting guidelines and documents. However, as compliance is a fundamental aspect of a medical device company strategy to position itself on the market, it is worth dedicating time and resources to stay updated on the Medical Device Coordination Group news and participate in their consultations.
Whether your company needs to streamline regulatory processes, enhance product quality, increase market access, or need support to stay compliant (and competitive) in the EU market, you can count on ECLEVAR to find the guidance your team needs. Contact our experts to learn more.
What You Have Learnt in This Article: Some Key Takeaway Points
- MDCG stands for Medical Device Coordination Group. This group provides expert guidance on medical device regulations in the European Union.
- The group developed a regulatory framework that ensures compliance with applicable regulations in the EU.
- These guidelines cover various aspects of medical device European regulations and provide guidance on how to stay compliant.
- The Medical Device Coordination Group shares information through various channels about new guidance and updates.
- Consultations are open to interested parties who wish to contribute to the developing process of guidance on medical device regulations.
- Following guidance is beneficial as it can streamline regulatory processes, enhance product quality, and increase market access.
- Future guidelines developments may include updates that address cybersecurity concerns and standardization of labels and classification.