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?
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.
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.
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 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 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.
Due to the significant changes within the regulation, Medical Device companies will experience several new changes, including:
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 ProPharma Group, 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.
Start with a pre-assessment:
Conduct a gap analysis and determine the actions you need to take:
Undertaking this process can be daunting. For help getting started, contact ProPharma Group for a no-obligation consultation today.