Navigating the labyrinth of compliance in the medical device industry can be a daunting task. The recent introduction of the Medical Device Regulation (MDR) by the European Union has added another layer of complexity. However, it also presents a golden opportunity for manufacturers who are well-prepared and strategic in their approach. This comprehensive guide will walk you through the essentials of selling under MDR, providing you with a roadmap to successfully manoeuvre the changing regulatory landscape.
1. Understanding the EU MDR
The European Union Medical Device Regulation (EU MDR) is a transformative set of regulations governing the production, distribution, and sales of medical devices within Europe. To continue trading within the European marketplace, medical device companies need to ensure compliance with these regulations.
If your organization was previously compliant with the Medical Devices Directive (MDD), you might need to reevaluate your standing. The MDR introduces numerous changes that demand your attention.
1.1 Why Was an Update Needed?
Several factors necessitated an update from the MDD. For instance, since the MDD was enacted in 1992, the medical technology landscape has evolved significantly. Innovations such as software as a medical device (SaMD) were non-existent back then.
Moreover, the European demographic has aged, and there's a growing demand for transparency in terms of medical device technical information. The new MDR regulation addresses these evolving needs, pushing for wider compliance with standardized regulations throughout Europe.
1.2 Structure of the EU MDR
The MDR document spans 174 pages, comprising a 13-page introduction, 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). The document is significantly more comprehensive and detailed than its 60-page predecessor, the MDD.
Further, there are 42 published implementing acts to clarify or implement the MDR and 12 delegating acts for modifying or amending it. This expanded content is a result of the integration of the Active Implantable Medical Devices Directive (AIMD) into the MDR, among other new elements.
1.3 Thematic Changes in the EU MDR
The new MDR shifts focus from the pre-approval stage of medical device manufacturing towards a lifecycle approach. The regulation emphasizes the responsibilities of medical device companies for their products throughout their entire lifecycle. This change is particularly crucial considering the aging population of 500 million people in the European market, who may face greater risks associated with medical device malfunctions.
2. Scope and Coverage of the EU MDR
The MDR defines "medical device" as an "instrument, apparatus, appliance, software, implant, reagent, material, or other article" with various uses, including disease diagnosis, prevention, monitoring, treatment or alleviation. This broad definition encapsulates numerous existing devices.
Moreover, the MDR has expanded the list of products that need to obtain a CE marking. This inclusion encompasses products used for disinfection or sterilization of medical devices and devices used for conception control, among others.
However, the MDR provides some relief to manufacturers depending on their device classification. Class I devices are exempt from having their QMS audited by a third-party auditor (notified body).
2.1 Coverage Under Annex XVI of the MDR
Annex XVI of the MDR introduces additional products that need to comply with the MDR requirements. These include:
Contact lenses and other eye products
Products introduced into the body surgically for anatomical modification
Products and substances used for facial or other subcutaneous fillings
Equipment used for liposuction, lipolysis, or lipoplasty
High-intensity radiation equipment for tattoo and hair removal
Equipment using electrical or magnetic currents to stimulate the brain
The inclusion of these products in the MDR addresses the gaps in the previous MDD, especially for devices used in procedures that evaded regulation due to their cosmetic nature.
3. Enhanced Traceability and Technical Documentation under MDR
The MDR mandates a Unique Device Identification (UDI) system, facilitating the traceability of all medical devices sold within the region. Devices must have a device identifier (DI), and each batch or production series of the product has a production identifier (PI).
The MDR also introduces new databases for clinical investigations, product registration, and post-market surveillance. The EUDAMED database is part of several databases providing access to the latest data on medical devices available in Europe.
4. Impact of MDR on CE Markings
The MDR significantly alters the process of obtaining and maintaining a CE marking. The CE marking permits the free trade of a medical device within the European Economic Area (EEA), ensuring the device meets all standards for patient safety and environmental protection.
Major changes include the appointment of a Person Responsible for Compliance, stricter Notified Body review, and the need for continuous maintenance of the CE marking. The CE marking certificate is valid for five years, but manufacturers are required to undergo random audits, maintain ongoing technical documentation, and perform extensive post-market surveillance.
5. Clinical Evaluation Requirements Under MDR
To acquire a CE marking, the MDR requires manufacturers to submit clinical evaluations in the form of a Clinical Evaluation Report (CER). The CER provides crucial data on a device's safety and performance and is part of the conformity assessment process.
The MDR introduces systemic changes to clinical evaluations, including potential reclassification of in vitro diagnostic devices and a more stringent comparative evaluation process.
6. Impact of MDR on Quality Management Systems (QMS)
Under the MDR, the previous "directives" for quality systems no longer exist or apply. Instead, they are transformed into "regulations," bearing a stronger legislative impact. Manufacturers must adhere to what are now known as "General Obligations" to ensure QMS compliance.
The MDR states that manufacturers must establish, document, implement, and maintain an effective QMS throughout the device lifecycle. This includes a quality manual and written policies and procedures covering various aspects such as design control, verification, validation, manufacturing stage assurance, and relevant tests and trials.
7. Marketing and Selling Medical Devices under MDR
The EU MDR does not provide specific guidelines for sales and promotion. However, it emphasizes the importance of not misleading the user regarding the device's intended purpose, safety, and performance. As a marketer, you must ensure that your promotional material aligns with the device's intended purpose and does not provide any misleading information.
7.1 Marketing to Patients vs HCPs
The EU MDR does not distinguish between promotions for patients or end consumers and HCPs. However, individual country regulations often impose stricter rules for marketing directly to patients.
7.2 Marketing on Social Media
While the EU MDR does not mention specific digital channels, you can advertise a medical device on social media as long as it conforms to the device's intended purpose. However, you must understand your target countries' rules and regulations.
7.3 Comparative Advertising
The EU MDR mandates that advertisements cannot be misleading. So, while you can compare devices in your marketing, the intended purposes of the compared devices should be similar.
8. Partnering for Success in the MDR Era
The complexity of selling under MDR can be challenging. However, partnering with a distributor can offer an efficient solution. Choosing the right partner can save you the cost and time of establishing your own sales force and acquiring the necessary know-how, especially considering the cultural, linguistic, and regulatory variations within Europe.
8.1 Why Choose Us As Your Partner
We are an experienced team with a deep clinical understanding, an extensive network of partners and Key Opinion Leaders (KOLs), primarily in the respiratory field, and proficiency in the five most critical European languages: English, French, German, Italian, and Spanish. Our cultural and linguistic competence gives us a significant advantage in customer retention and understanding.
9. Navigating the Future of EU MDR
Although the MedTech industry and the EU MDR are constantly evolving, with a future-proof strategy and the right partner, you can ensure compliance throughout the product lifecycle. Our MedTech Lifecycle Excellence (MLE) Platform is designed to facilitate end-to-end product lifecycle excellence from ideation to commercialization to postmarket surveillance.
10. Conclusion
Successfully selling under MDR requires a deep understanding of the new regulations, a strategic approach, and the right partner. With these elements in place, you can navigate the changing regulatory landscape and seize the opportunities that the new MDR presents. As your experienced, patient-centric, and innovative partner, we are here to guide you through this journey.