In May 2021, the new European regulations on medical devices (EU MDR) will take full effect.
Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions to the Medical Device Regulation compared to its Medical Device Directive predecessor. For the record, the complete document is nearly 3 times longer.
What should you be aware of to successfully place your device(s) on the European market? How can you prepare to efficiently implement all new directives? How do those changes affect your resources in terms of personnel, time constraints, and budgets?
MDD to MDR – What Has Changed?
The MDR has the most significant effect on medical device companies, manufacturers, and regulators. Regulatory bodies have been under pressure to tighten medical device regulations and better ensure patient safety after the Poly Implant Prothèse implant, metal-on-metal hip implants, and pelvic floor mesh scandals.
It is now less a matter of how to obtain approval than how to retain it throughout a product’s lifecycle. The EU is putting greater emphasis on safety measures, risk management, post-market surveillance, and data collection and exchange. While compliance starts before submitting to regulatory agencies, heightened scrutiny after a device has been approved is a new, keenly focused target.
Some devices or device families previously escaping regulation have been added, including cosmetic fillers, products used to clean and sterilize equipment and devices, as well as non-medical products like epilation lasers.
Some devices may now belong to a new, higher-risk class, forcing manufacturers to adhere to stricter standards.
Unique Device Identification (UDI)
In an effort to enhance transparency and traceability, devices – excluding custom-made – will be labeled with a UDI. The core data elements will be accessible to the public.
Labeling, packaging & instructions language
The MDD stated that “Member States may require […] the information accompanying the device in the national language(s)”.
Under MDR, language requirements take a stronger approach: “Manufacturers shall ensure […] the information accompanying the device is in the national language(s).”
On top of this, all information pertaining to the device must be published on the manufacturer’s website in the official language(s) of the intended market(s).
The European Union has 23 official languages, so the new directives will require coordination across languages and regions.
No grandfathering within the MDR. All existing devices that reach a certification renewal deadline must be compliant with MDR.
Clinical evaluation based on equivalence must be demonstrated on technical, biological and/or clinical levels, necessitating access to competitors’ data.
Post-market surveillance and risk management
Post-market clinical follow-up (PMCF) requirements upgrade from “ongoing” in MDD to “continuous” in EU MDR. Manufacturers must report all device-related incidents (death, injuries) into EUDAMED (see next item). It is also worth noting that device incidents that do not incur death or serious health deterioration must be reported within 15 days (vs 30 days in MDD). Pharmacovigilance becomes one priority.
Data transparency and accessibility
Data on actors, product identification, manufacturers, clinical investigations, notified bodies, and others, are collected, stored, and accessible via EUDAMED. The portal aims to become a collaborative and inter-operable system – open to the public – as EUDAMED.
EU MDR Challenges for the Life Sciences Industry
Due to the significant changes within the regulation, Medical Device companies will experience several new changes, including:
- Costs to comply may be greater than budgeted
- Conforming to changes for existing devices will require time and human capital commitment
- There may be impacts to the supply chain if a partner decides to discontinue work in the EU
- The cost of remediation may drive up the market price of devices
- Increased clinical data requirements create added responsibility to companies that have not had these types of requirements previously
- The cost of remediation vs revenue must be weighed, potentially leading to the withdrawal of products from some markets
Getting ready requires having a structure in place and everyone on board. It may prompt you to reassess your goals and evaluate your expertise in European regulatory affairs. Complying with EU MDR will require an overhaul of core processes and procedures and will necessitate additional staff.
At Treximo, we know the EU market well, and we’ve been actively working toward setting up efficient roadmaps to navigate the transition as smoothly as possible. From a structural standpoint, we’ve created a Project Management Office to efficiently address priorities and manage timelines. At the organizational level, we can quickly bring project managers, EU regulatory experts, and consultants on board to help you hit the ground running.
This change of legislation for medical devices requires a structured plan and approach. Here’s a sample 4-step implementation model that can be used for your implementation:
1. Conduct Current State Assessment
Start with a pre-assessment:
- Conduct product portfolio assessment
- Assess classification changes
- Analyze and identify the costs incurred to meet new regulations (per product family)
- Assess EU MDR impacts on your partners (e.g. suppliers, distributors)
2. Conduct Gap Analysis
Conduct a gap analysis and determine the actions you need to take:
- Clinical evidence
- Risk management
- Device labeling
- Post-market surveillance
- Traceability requirements
3. Implementation Roadmap
- Create overarching program structure (e.g., develop an overarching project plan and charter for effort)
- Establish milestones, especially for certificates expiry dates
- Schedule cross-functional progress meetings, efficiency reviews, and post-execution monitoring
4. Update/Introduce Processes
- Identify new or updated regulations to be addressed for your QMS
- Develop new process documentation and supporting templates/reports
- Designate or enhance key roles (e.g., PRRC)
Help with Medical Device Regulation Requirements in Europe
Undertaking this process can be daunting. For help getting started, contact Treximo for a no-obligation consultation today.