EMERGO SUMMARY OF KEY POINTS:

• European Competent Authorities’ new roadmap lists implementation and compliance priorities for new Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR).
• The roadmap priorities suggest regulators are aware of which implementation areas present the biggest challenges for industry.
• Implementation timelines have not been included in the new roadmap, however.

European Competent Authorities have issued their official roadmap for implementation of the Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR), providing device manufacturers more clarity in terms of prioritizing compliance efforts.

The Competent Authorities’ roadmap prioritizes major implementation and compliance issues across eight major areas, which we discuss below.

According to Ronald Boumans, Senior Global Regulatory Analyst at Emergo in The Netherlands, the roadmap generally indicates that Competent Authorities are aware of which MDR and IVDR implementation areas present the biggest challenges for industry as well as regulators and other stakeholders. But the lack of deadlines in the roadmap may cause additional uncertainty.

“It is good to see that the authorities are working on guidance documents and templates for subjects where industry was in need of support,” Boumans says. “This appears to be a concise list of tasks and priorities, but timelines are missing. Has too much work been cramped into too short a period?”

Clinical evaluation/performance evaluation

European authorities consider clinical evaluation issues such as guidance on device equivalence and clinical evidence; MEDDEV 2.7/1 gap analysis; interfacing between documents and reports; and developing guidance on IVD performance evaluation and clinical evidence as high priority, according to the roadmap.

Medium-high priority has also been assigned to template document development efforts covering Summary of Safety and Clinical Performance (SSCP), Summary of Safety and Performance, Clinical Evaluation Assessment Report and related clinical documents for medical devices and IVDs.

MDR/IVDR scope and classification

Under scope and validation issues, the roadmap lists classification guidance for IVDs as well as common specifications for Annex XVI medical devices as high priority.

Boumans points out that the roadmap identifies guidance on companion diagnostics and combination products under this section as low-priority. “This appears to be in contradiction to the fact that these are new concepts introduced as high-risk devices in the MDR and IVDR,” he observes.

Notified Bodies and conformity assessment

Most efforts the roadmap identifies as pertaining to Notified Bodies and conformity assessment are given high priority, including work on scopes for designation; guidance documents to address joint assessment processes; evaluating and training conformity assessors; and clarifying conformity assessment procedures for Notified Bodies.

Post-market surveillance and vigilance

Top among efforts under the MDR/IVDR post-market surveillance and vigilance area are developing guidance documents for vigilance reporting under the new Regulations, as well as establishing terminology for adverse nomenclature and patient harm applicable to both medical devices and IVDs (completion of the terminology activity is expected in 2018).

Eudamed and UDI

Competent Authorities cite issues including simplified registration and interoperability of the Eudamed database, Unique Device Identification (UDI) guidelines for manufactures, and guidelines for UDI carriers and related data as top priorities under the Eudamed and UDI area.

Market surveillance

Interestingly, all activities under the market surveillance area—cooperation between Competent Authorities, high-level guidance development for economic operators, defining market surveillance activities and related issues—have all been relegated to medium-priority status. Boumans suggests this reflects authorities’ near-term focus on supporting industry compliance with the MDR and IVDR.

“All market surveillance work has a medium priority, which signals that the Competent Authorities are giving priority to helping industry be compliant with the new Regulations,” Boumans says.

IVD-specific activities

As the IVDR will introduce significant changes to European regulatory requirements for IVD devices, the roadmap lists IVD-related activities in this section as high-priority. Issues including designation of European reference laboratories and assessment of Class D IVDs are included in this section as high-priority activities.

Over-arching priorities

Finally, the roadmap addresses broader MDR and IVDR issues requiring attention by both regulators and industry to support full implementation of the Regulations.

Among high-priority activities included in this section is ensuring availability of Authorized Representatives (ARs) in Europe that will be capable of assuming enhanced legal responsibilities such as product liability that the new Regulations will impose.

“This section, among other things, addresses the availability of Authorized Representatives,” observes Boumans. “This could be seen as an indication that the Competent Authorities acknowledge that ARs are brought into a more challenging position under the MDR and IVDR.”

Additional European MDR and IVDR resources from Emergo:

• European CE Marking consulting for medical device companies
• CE Mark consulting for IVD companies
• European Authorized Representative in-country representation
• European MDR gap assessment and transition support
• European MDR on-site training
• Whitepaper: Understanding Europe’s MDR 2017/745
• Whitepaper: Understanding Europe’s IVDR 2017/746