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The EU Roadmap has been published. But it represents a dawning of a hard truth. The EU medtech sector still has a long way to go along the road to implementation before it gets the clarity it needs.

 

 

RoadSign 

 

 

While there is a sense of relief that the Medical Devices Regulation/IVD Regulation Roadmap has been published, it also serves as a reality check for the sector.

 

 

Despite how the document has been described in the lead up to its release, this is not a roadmap to implementation. Rather, it is a roadmap to creating what will effectively be the real roadmap to implementation.

 

 

The roadmap, finalized Nov. 10, includes eight broad "work streams," does not tell stakeholders in the sector what work is now needed to comply with the regulations. Instead, it contains a series of instructions, mainly to the EU's working groups, on the work that they need to carry out – much of it comprehensive and detailed – to create the documents, guidance and structures on which implementation can then be built.

 

 

The sector is one step removed from where it should ideally be now that the regulations have entered into force, and there is a long way to go before there is consensus over how the new requirements should be interpreted. It still seems like a tall order for all of the involved parties to complete the necessary work and issue the documents so that full implementation can take place on May 26, 2020 for the Medical Devices Regulation and May 26, 2022 for the IVDR.

 

 

For now, manufacturers keen to get on with compliance are working through many of the stages in the dark, or, if they are lucky, in the dim light. But in these conditions, it is still easy to make mistakes that could be costly to correct. Other manufacturers may take this state of affairs to decide it is still too early to start on compliance; but this would be against generally perceived wisdom from medtech regulatory experts and notified bodies.

 

 

"The detail in this document is likely to evolve as the work programs develop," the Competent Authorities for Medical Devices group, which worked the European Commission on the roadmap, says on its website. What is more, the European Commission has invited the medtech sector to let it know of editorial errors in the regulation documents, but this may well lead to comments on inconsistencies and anomalies in the text, too. (Also see "EU Commission May Open Floodgates By Inviting Input On Editorial Errors" - Medtech Insight, 18 Oct, 2017.) Overall, it appears there could still be several moving targets and nothing is quite set in stone.

 

 

Also, there is a question of where the resources to carry out all this new work will come from. Most of the efforts must be completed by representatives of the national medtech authorities in their roles on the Commission's working groups. It is already well known how stretched these individuals are in terms of time and how short-staffed many of the authorities are.

 

 

Guidances Documents And Priorities

That said, the industry is still at a landmark juncture. The roadmap document was issued several months later than had been expected, but it now provides clear signposting to the work that needs to be done.

 

 

"The detail in this document is likely to evolve as the work programs develop," the Competent Authorities for Medical Devices group says.

 

A glance through the tables, shows that the intended outcome of much of the work will be in the form of guidance documents.

 

 

While the work items are currently assigned a generic priority of high, medium or low, these priorities are due to become more defined and specific by the individual working groups tasked with each activity.

 

 

CAMD says in an introduction, that it is important to note that, although the MDR and IVDR have specified implementing acts (some 118 in total, Medtech Insight notes), additional guidance and information will be needed in advance to fully define how certain provisions are to be applied.

 

 

What form the guidance documents will take and how they will be issued still needs to be worked out in future discussions on specific topics, CAMD says.

 

 

The newly finalized document notes that, while such guidance will not have a legal basis, they are intended to be valuable tools to assisting a harmonized approach to implementation.

 

 

IVDs generally have been incorporated into the work streams of the roadmap, but the IVD-specific work stream has also been retained to allow issues specific to IVDs to be addressed.

 

 

One particularly important and heavy work stream is the one that relates to the development of the new Eudamed medical device database. Within this stream, there are three high-priority work items:

 

 

  • Uniform input into the design/development of a functioning Eudamed medical device database;
  • Guidelines for manufacturers on Unique Device Identification assignments (e.g., when is a new UDI or basic UDI-Device Identifier necessary); and
  • Guidelines on UDI carriers and UDI marking.

This last item is one of only two areas in the document where industry is mentioned – it is given co-ownership of the work with the UDI taskforce within the Commission's UDI working group and will be evaluating issues including: how to control UDI labeling inside the manufacturer's quality management system; where to put the UID carrier in case of implants; and where to put the barcode on the device or parts of a device system.

 

 

Meanwhile, its noteworthy that the entire "market surveillance" work stream has been labeled as a "medium" priority. Some may question whether a high priority should have been given to the production of general high-level guidance and infographics for economic operators (EOs) clarifying expectations around: EO obligations; responsible persons; liability; interaction with Eudamed; and registration requirements.

 

 

"High-Priority" Roadmap Work Stream Items

 

Work Stream

High Priority Work Items

1

Clinical Evaluation & Clinical Investigation (medical device);

Performance Evaluation & Performance Studies (IVDs)

Clinical evaluation work package, including:

*Guidance on equivalence, well established technologies, clinical evidence

*Gap analysis of MEDDEV 2.7/1 (EU clinical evaluation guidance)

*Contribution to relevant Implementing Acts

*Work on interface between various documents/ reports

*Contribution to guidance on performance evaluation and clinical evidence for IVDs

(The priority level of clinical evaluation-related template document development is marked as "medium/high.")

2

Scope & Classification

Classification guidance for IVDs around classification rules and scope, giving practical examples

Common Specifications for annex XVI products (non-medical/aesthetic)

3

Notified Bodies

Implementing act(s) with list(s) of codes/ corresponding types of devices to describe the scope of the designation

Guidance to be issued on re-designation process for joint assessments under the new regulations

Capacity and expertise of assessors – training based on a gap analysis

Conformity assessment – clarity over procedures for notified bodies and the meaning of technical documentation assessments on a representative sampling basis

4

Post-Market Surveillance & Vigilance

Guidance on requirements for vigilance reporting

* Identify gaps between the current MEDDEV guidance and the MDR and IVDR – issue as an interim guidance via CAMD website with a view to updating a MEDDEV guidance in due course;

*Details on how vigilance should be reviewed in clinical evaluation for device and performance evaluation for IVDs as well as the required detail of the investigations undertaken; and

*Focus on new manufacturer incident report (MIR) form, what vigilance looks like for member states, flag areas that are law rather than guidance and where MEDDEV needs to be updated to reflect the new regulations.

Develop and agree on terminology for device/IVD Adverse Nomenclature and patient harm: defining AE nomenclature to be defined and identifying patient harm nomenclature, including problem and cause investigation.

Terminology already underway at the International Medical Device Regulators Forum, completion expected by 2018

5

Eudamed & UDI

Uniform input into the design/development of a functioning Eudamed medical device database

Guidelines for manufacturers on Unique Device Identification assignments

Guidelines on UDI carriers and UDI marking

6

Market Surveillance

This entire area has been given a "medium" priority level. Some work is already underway at the competent authority level on market surveillance as part of the second tranche of implementation of the "Dalli action plan" in reaction to the PIP breast implant scandal. (Also see "Will EU’s New Market Surveillance Project Hit As Hard As Notified Body Action?" - Medtech Insight, 17 Nov, 2016.)

7

IVD-Specific Issues

Information to support the prompt designation of EU reference labs

Guidance on how class D IVDs can be assessed in the absence of Common Specifications

8

Over-Arching & Cross-cutting Priorities

This relates to transitional problems & uncertainties, and risks to continued supply of safe devices. (Also see "New 'Transitional Measures' Taskforce To Answer EU's Most Critical Questions" - Medtech Insight, 8 Nov, 2017.)

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