How helpful is the new EU guidance at this stage?

This month 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…

MDCG 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.  

·         For manufacturers, most interesting may be the first Q, which answers that NB informally must endorse MDCG guidance to reduce their risk.

·         Secondly, it confirms notified bodies under circumstances may continue to use consultants as subcontractors or hire them as employees.

·         But 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.

·         In the light of massive transfers ongoing, clarification on minimum activities to be performed by the new notified body is provided.

·         And 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

·         Interestingly, 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.

Overall, quite a useful document, both for notified bodies, as well as for manufacturers.

MDCG 2019-7 – PRRC in MDR and IVDR clarifies most open questions in relation to the person responsible for regulatory compliance.

·         Any 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.

·         Each 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.

Whilst the 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.

MDCG 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).

·         The document clearly calls out for member states to accept one EU Implant card, rather than having different national requirements apply

·         It also harmonizes size to credit card dimensions

·         Very 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.

·         The 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.

·         The system Implant Card allows for exchanging components of the system.

Very 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.

Two more documents are expected to be published shortly: guidance on the Manufacturer Periodic Summary Report (MPSR) and guidance on Summary of Safety and Clinical Performance (SSCP).

Looking at 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!

Gert W. Bos, PhD, Fraps
Post date: July 08, 2019
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