Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time

Interview posted on 02 July 2020 on Medtech Insight
Author: Amanda Maxwell | Source of Original Article

Executive Summary

Preparing all items needed to support the implementation of the EU’s Medical Device and IVD Regulations in time is going to be impossible. Competent authority expert Thomas W Møller explains how work on a third of implementation tasks still remains to be started.

As controversial as this may sound, it will be impossible to produce guidance on all aspects of the implementation of the Medical Device Regulation by 26 May 2021.

However, “those overseeing implementation need to continue to work together to prioritize what is needed and to manage the roadmap to MDR implementation while remaining realistic about what is achievable.”

That is the view of Thomas W Møller, section manager of medical devices at the Danish Medicines Agency, who has been newly elected as chair of the executive board of the EU’s CAMD (Competent Authorities for Medical Devices) group.  (Also see “Denmark’s Møller Named Executive Board Chair At Medical Device Competent Authorities Group” – Medtech Insight, 10 Jun, 2020.)

Medtech Insight asked the new incumbent how he sees CAMD’s role progressing in terms of helping the medtech sector prepare for MDR implementation.

Medtech Insight: What do you see as the single most important task for CAMD this year?
 
Thomas W Møller: To ensure that the MDR and IVDR are up and running in a timely fashion and as comprehensively and transparently as possible, while remaining realistic about what is achievable.
 
When did you last update the roadmap which lists the activities needing to be completed to ensure the regulatory structure is in place for all actors to be able to fully comply with the MDR and IVD Regulation?
 
Møller: CAMD has recently updated the 14-page roadmap which lists, according to priority, all the activities that are essential or desirable in the context of the MDR and IVDR.

The roadmap drawn up by the CAMD Operational Working Group (OWG) is now used as a priority listing to help identify the key issues to be addressed, when and by whom, with industry and other stakeholder input too.
 
How much progress has been made on the activities listed in the roadmap?
 
Møller: Of the 165 separate items listed, 50 have been completed., while 47 are ongoing and 68 have not even been started yet.

In terms of having these 165 activities ready for the 26 May 2021 MDR application date, however, this is just not tenable. We have grouped these remaining activities as “necessary, important, or nice to have” to create a prioritized list moving forward towards the implementation date.
 
Can you break down where most tasks have been completed, where they are ongoing and where they have not started yet?
 
Møller: The following table shows the progress in each technical area or work stream as of January 2020:
 

Technical areas/work streams

 DoneOngoingStill to start

 

     1


Clinical evaluation & clinical investigation (MD); performance evaluation & performance studies (IVD)

 
   6

     9

  11

     2

 Scope & classification  11    2   2

 

    3


Notified bodies & conformity assessment

 
  10

    5

   5

    4

Post-market surveillance & vigilance for both MD and IVD   4     8  6

 

    5

 
Eudamed & UDI

 
  10

     7

  8

    6

Market surveillance    2     4  19

 

    7

 
IVD-specific issues

 
   5

     3

   9

    8

Over-arching & cross-cutting priorities   2     9   8

 

TOTAL

 

 
  50

    47

  68
 
What are CAMD’s other most significant priorities?
 
Møller: To ensure that medical devices are moved higher up the EU agenda. This is an underfunded area. Given that the European Commission is proposing investing E9.4bn (S10.6bn) in strengthening health systems, compared to the previous commission proposal of E413m under the European Social Fund, medtech should receive greater attention. One particular area that deserves more focus is patient surveillance.

At national level, too, more needs to be spent on medtech oversight. In Denmark, we tripled our medical device budget between 2018 and 2020 to DKK43m (S6.4m).
 
To what extent has COVID-19 impacted the roadmap priorities?
 
Møller: The upheaval caused to life in general by COVID-19 has not altered CAMD’s priority listings, although that it spurred the commission decision to delay the MDR application date by a year.

The learning points from the pandemic are varied, not least because each EU member state is responsible for its own health and welfare systems and the ways in which they are managed and funded. That said, questions arising over the certainty of supply will need to be addressed at EU level.
 
What are the current key specific challenges for the MDR/IVDR Operational Working Group ̶ formerly known as the MDR/IVDR Transition Subgroup?
 
Møller: Now that the implementation deadline has been delayed by a year and the sector is also coping with the fall-out of the COVID-19 pandemic on the full application of the MDR in particular, this will probably mean a significant amount of new work for the OWG.

Our overarching priorities are: guidance on clinical requirements; guidance on transitional provisions; a general monitoring of notified body capacities based on information received from authorities/stakeholders/others; the Eudamed medical device database delay; and coordination with the Medical Device Coordination Group (MDCG).

We will also have to keep reviewing the priorities and targets that we had scheduled, before the pandemic hit, for the May to November 2020 period. These were:
Guidance on performance evaluation for IVDs
Guidance on notified body technical review

 

Common specifications for annex XVI products for medical devices

 

Implementing act on reprocessing single use devices (SUDS)

Guidelines on vigilance reporting MDR (Articles 87-90)

Identify gaps between the current MEDDEV guidances and the MDR

 

Where to put the barcode on the device or on parts of a device system?

 

Guidance for in-house medical devices

Resources requirements: identification of issues with implementation due to lack of expertise and resource


National competent authority market surveillance obligations in accordance with Article 93 (MDR) and Article 88 (IVDR)

 

Production of general, high-level CAMD guidance/infographics for economic operators (EO) clarifying expectations around EO obligations, authorized representatives and liability for the responsible person

 

 

Guidance on new classification rules/changes to existing rules of MDR, e.g. MEDDEV 2.4/1 update/addendum

 
How much work are you doing on the IVD Regulation at CAMD?
 
Møller: At the moment, given the MDR demands and the extent to which medtech competent authorities are underfunded, we have not yet been able to focus much on the IVDR. This is a concern for us all as the IVDR probably represents an even bigger mountain to climb than the MDR.
 
The executive group of CAMD has been active in lobbying for the EUDAMED medical device database to be released in parts rather than waiting to release it as a whole. Are you satisfied with the progress you have made?
 
Møller: Given that EUDAMED is not going to be ready in time in its entirety by 26 May 2021, releasing it in parts is the best possible option. These parts will be voluntary to begin with.

When we held an around-the-table review at our last meeting on how many countries would use Eudamed in first instance, a large majority of countries were in favor of using the parts of EUDAMED as and when they are released. It is important for industry that the response of the authorities is as harmonized as possible. The Danish authority would welcome working with EUDAMED parts as soon as they are ready. We consider that EUDAMED is critical for how competent authorities operate in the context of the regulations.
 
How much progress has been made with regard to market surveillance? What are the headline news points here and what should we expect next?
 
Møller: CAMD is still working on the market surveillance plan as a spin off from our Joint Action on Market Surveillance of Medical Devices (JAMS) project we set out at our first meeting in Lisbon on how to do harmonized inspections. We are also working on market surveillance in the area of IVDs.

CAMD and MDCG – What Are Their Different Roles?

Both the MDCG and the CAMD are made up of representatives from the national medtech agencies.

MDCG is legally formalized in the Medical Device and IVD Regulation and part of the European Commission’s organization framework, whereas CAMD has been established longer, is more modelled around the concept of an association of competent authorities and is more informal.

Given that the commission’s medtech staff is limited, the work that the MDCG does in supporting implementation and developing guidance documents and delegated and implementing is vital, as is the work it does in designating and supervising notified bodies, amongst other roles.

Many national agencies would argue that they are underfunded in the medtech area, but a team approach is taken to ensure that the regulations work as optimally as possible.

The CAMD and MDCG work programs interlink; many of the people that play a key role in CAMD, are also representatives on the MDCG – indeed, there is usually some 60-80% overlap at meetings. The decision over who attends these meetings depends on national medtech regulatory infrastructures and how they operate, as well as what is on the MDCG’s agenda.

In some counties, for example Denmark, where responsibility for medtech all comes under the Danish Medical Devices Agency, the same representatives are often present both at the MDCG and the CAMD meetings.

In other countries, however, where responsibility for medtech is split between different agencies or between the central and regional authorities, the representatives attending MDCG and CAMD meetings may be different more frequently.

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