Medical Regulations: The Complete Guide to the Transition to EUMDR
What are the current regulatory standards for medical equipment? This is a guide to the latest medical regulations and the transition to EUMDR.
The European Union has the second-largest medical device market after the US. You don't want to jeopardize your participation in this large and growing market. Have you made the transition to the EUMDR yet? Do you know how these medical regulations affect the devices you have on the European market? Learn more about the EUMDR and what it means for your business. You'll have a better idea of what you need to do to stay compliant and competitive.
What Is the EUMDR?
The European Union Medical Device Regulation 2017/745 (EUMDR) regulates medical devices. It applies to products on the market in the EU. The new regulations replace the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The EUMDR is supposed to improve the quality, reliability, safety, and performance of medical devices. The European Commission wanted to reduce health impacts from hazardous substances in medical devices. The regulations restrict certain substances that:
- Can cause cancer
- Change genetic material
- Are toxic for reproduction
The EUMDR also restricts some substances with endocrine-disrupting properties. The regulations establish a maximum threshold for these substances. Chapter II of annex I of the EUMDR contains these regulations. The EUMDR focuses on better traceability and transparency in the medical device supply chain.
Timeline for the Transition to the EUMDR
The EUMDR was adopted in 2017. The regulation included a three-year transition period, though. The transition period was supposed to end on May 26, 2020. In April 2020, the European Commission recommended a one-year extension. The COVID-19 pandemic was the reason for proposing this delay. The Parliament and Council approved the extension. The new deadline for complying with the EUMDR was May 26, 2021.
Devices with valid certificates that they received under the old directives have a grace period. The text of the EUMDR explains these transitional provisions in article 120 of chapter X. Devices with a certificate from before May 25, 2017 remain in compliance until the end date of the certificate's validity. The exception is devices whose certificates were issued under annex 4 to the AIMDD or annex IV to the MDD. Those certificates expire on May 27, 2022 at the latest. Devices with certificates issued on or after May 25, 2017 remain in compliance until the certificate's end date. The end of validity can't be more than five years after the certificate was issued. Certificates from on or after May 25, 2017 expire on May 27, 2024 at the latest. Class I devices that will require the intervention of a notified body for the first time under the EUMDR can be placed on the market until May 27, 2024. Distributors can continue to make the devices available, and end-users can put them into service, until May 27, 2025.
Changes to Medical Regulations
Many regulations remain the same under EUMDR compared to the earlier directives. EUMDR doesn't remove any of the earlier requirements. Annex XVII of the EUMDR gives a correlation table for sections of the new regulation compared to the earlier directives. Some of the requirements are stricter than before, though. New provisions are part of the regulations as well.
Not everything in the EUMDR applies to every product. The specific changes under the new regulations will likely vary from device to device. The text of the EUMDR is long and can be complex. A regulatory consulting company can help you determine how the new medical regulations apply to your products.
Medical Device Classification
The classification of medical devices is stricter under EUMDR than under the earlier directives. The new regulations include 22 rules for classifying devices. This is four more than the previous directives. Chapter V and annex VIII of the EUMDR describe the classification process and criteria. Classification rules take into account the potential risks associated with a device, its technical design, and the manufacturing process. The rules cover four basic categories of devices:
- Non-invasive devices
- Invasive devices
- Active devices
- Special rules
Non-invasive devices either don't touch the patient or only touch intact skin. Invasive devices go into the body. Active devices rely on a source of power other than gravity or power that the human body directly produces. Special rules cover devices that don't fit into the first three categories. Contraception, devices using non-viable tissues or cells, and devices incorporating nanomaterials are some examples. The EUMDR classifications have three levels. Class I devices have the lowest risk for patients. Class III devices are high-risk products. The new classification rules may result in a higher risk class for some devices.
Total Life Cycle Traceability
One important change to the EU medical regulations is the requirement for total life cycle traceability. The total life cycle includes all stages of product development and post-market activities. The EUMDR establishes a Unique Device Identification (UDI) system. The UDI system helps achieve supply chain traceability. The entire supply chain falls under the EUMDR. Third-party manufacturers and suppliers must comply with the new regulations. Manufacturers need a quality control system that includes clinical evaluation, post-market surveillance, and post-market clinical follow-up for every device.
Post-Market Surveillance Reporting
Section 1 of chapter VII of the EUMDR explains the requirements for post-market surveillance. Companies need to have a post-market surveillance report for all devices. The requirement even applies to Class I devices.
The report needs to summarize the results of the post-market surveillance data. It should describe any corrective actions that apply to devices on the market. Companies must file post-market surveillance reports within a certain number of days after receiving the data. You must report serious threats to public health within 2 days. The report of a death or serious deterioration of health has a 10-day time limit. You must report any other serious incidents within 15 days. Medical consulting services can help you evaluate the traceability of your current quality control. You can make any necessary changes and be sure you're meeting the new requirements.
Labels and Instructions for Use
Product labels and instructions for use have additional requirements under the EUMDR. The new rules have a greater focus on precautions and the presence of potentially harmful substances. Chapter III of annex I of the EUMDR lays out these new requirements for labeling and instructions.
Labels need a checklist of general safety and performance requirements. Any warnings, precautions, or contraindications must appear on the label. The UDI carrier needs to be on the device label or packaging. Labels need to indicate if any restricted substances are present at a level above 0.1% by weight. Class III and implantable devices need a summary of safety and clinical performance on the label.
Instructions for Use
Instructions for product use need to inform the user of the device's purpose, proper use, and any precautions. If the device label uses symbols to transmit information about the product, the instructions for use need to explain what the symbols mean.
The European Database for Medical Devices (EUDAMED) will eventually be an important part of complying with EUMDR regulations. Modules of the system are gradually coming online. EUDAMED is scheduled to be fully operational next year.
EUDAMED will have several functions. The goal is to increase transparency. The database will coordinate the information available about medical devices on the market in the EU. For example, the public will be able to access safety and clinical performance data for medical devices. Companies will need to have their UDI registration and approval certificates in the database. Companies will also put their post-market surveillance data into EUDAMED.
Making the Transition to the EUMDR
The transition to the EUMDR can be complex to navigate. Companies have increased requirements for quality control, product labeling, and clinical testing. They will need to maintain updated records in the EUDAMED database. At Trinity M Consulting,LLC. we can help you comply with the new EUMDR regulations. We provide customized medical regulatory consulting for the medical device industry. Contact us today to be sure you're in compliance with these important new medical regulations.