Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time
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.
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.
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.
Technical areas/work streams
|Done||Ongoing||Still to start|
|Scope & classification||11||2||2|
|Post-market surveillance & vigilance for both MD and IVD||4||8||6|
|Over-arching & cross-cutting priorities||2||9||8|
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).
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.
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
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.
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.