already we saw 3 new guidance documents being published on the EU Commission
website, and they are massively distributed in social networks. And two more
are expected on very short notice. But how helpful is this additional guidance
in times where manufacturers should be finalizing their applications under the
EU-MDR? Let’s have a look and reflect…
2019-6 - Q&A in relation to notified bodies contains answers on quite a few questions in
relation to the joint audits. It follows up and answers quite a few issues
where notified bodies when comparing notes from their joint inspections believed
there was yet a harmonized approach to be found among the members of the authorities’
audit teams. This document tries to bring the clarity looked for, bringing the
harmonization in notified body expectations one step further. Critical in a
stage where many notified bodies are addressing the series of deficiencies
identified in their joint audits.
manufacturers, most interesting may be the first Q, which answers that NB
informally must endorse MDCG guidance to reduce their risk.
it confirms notified bodies under circumstances may continue to use consultants
as subcontractors or hire them as employees.
most debated is the statement that pre-certification work is not allowed before
an application is lodged. So, no early MDR audits, and start of dossier
reviews, until the notified body is formally designated, and notification thereof
is published in Nando.
the light of massive transfers ongoing, clarification on minimum activities to
be performed by the new notified body is provided.
for some quite critical, it clarifies what must be available to an own brand
labeler as stand alone manufacturer (note 4), which seems to be a bit more
relaxed than initially anticipated
some notified body activities such as assessment on reprocessing of single-use
devices have been excluded from the joint audit, bringing these elements back
into national supervision. A logical choice in relation to national freedom to
allow or forbid such processes under national law.
quite a useful document, both for notified bodies, as well as for
2019-7 – PRRC in MDR and IVDR clarifies most open questions in relation to the person responsible for
qualification acquired outside of EU should be recognized by one of the review
boards in an EU member state that governments have put in place for acceptance
of foreign education. An unexpected burden.
legal entity needs to have its own PRRC, so many constructs of sharing a PRRC
(system) between various legal entities in a large cooperation with roles of
manufacturer and authorized representative have become challenging.
document is not fully empowered due to the repeated soft wording ‘should’,
‘may’ and ‘it must be assumed’, it brings some clarity. It does however not
address the most asked question in relation to potential personal liability and
changes of being charged in court together with the formally recognized
liabilities of legal manufacturer, importer and authorized representative.
2019-8 – Implant card
is deemed by many the most helpful new document at this stage. Not in the least
because of its clarification and stimulation of the use of some new symbols
(although not listed in a harmonized standard yet).
document clearly calls out for member states to accept one EU Implant card,
rather than having different national requirements apply
also harmonizes size to credit card dimensions
importantly, it spells out that data in fields of these newly introduced
symbols do not need to be translated on the implant card itself. Only the
device type section contains translatable elements. An annex with formal
translation of symbol meaning can be utilized in the IFU, or in a separate
leaflet provided with the implant card.
document in various places puts emphasis on providing an information leaflet
for the healthcare provided, in addition to the implant card. Of course,
validation testing should be completed before releasing such a document.
system Implant Card allows for exchanging components of the system.
helpful indeed this document, especially also due to the examples and graphical
illustrations. And very timely, as today IC questions are at the forefront of
the implementation train.
documents are expected to be published shortly: guidance on the Manufacturer
Periodic Summary Report (MPSR) and guidance on Summary of Safety and Clinical
the overall content and clarity of the guidance, these documents truly help the
harmonization along, and they provide an answer to at least a direction on many
of the questions that circulate in the Medtech community. I can’t wait to see
the final version of the next two guidance documents being posted!