We live in interesting times is typically the second phrase I hear on the many calls and virtual meetings I have each day. It immediately follows the question on how I am, and how the family is doing. Still a few seconds in between, so if you want you can say something on the situation. But we seem to get closer to just moving on. As we all are in a hurry, with busy agenda’s, managing home schooling and more.
As authorities are putting huge efforts on getting their grounds covered, literally with new hospitals, new equipment, trained IC staff and more, guidance and rules on what they expect, and how their special market access rules work, are sprouting rapidly.
A quick scan sees that we are approaching 100 documents, the vast majority of which take the form of guidance; second category are notices and rules; and actually one form (UK). Topics are the largely the same (exemptions on IVD kits and medical products, specifications of product groups, alternative to quality system rules, state of alarm rulings), but solutions are slightly different everywhere. Some would focus on correct and clear product claims, others force manufacturers to inform about upcoming shortages.
Many of the guidance documents are published by WHO, covering many of the basics on behalf of all. More specific rules are published by economies in BRIC / IMDRF as well as some others, typically 5-8 key documents per jurisdiction. Remarkably, the EU only published 2 core documents, one on export authorization (EU 2020/402) and one on sharing national exemption clearance (EU 2020/403). National authorities in EU all take up their individual roles, as the national healthcare is a key area that is not organised EU wide. UK, stepping out of the EU at the end of this year, has published a very helpful stay at home guide in many languages to ensure all people in their territory will be able to clearly understand the expectations to them personally.
In addition, many jurisdictions are taking measures on audits, either by postponing foreign inspections such as the FDA announced for all except for mission-critical inspections, or by moving them as needed into virtual audits, a route typically taken by EU Notified Bodies. Most critical in that aspect is that some notified bodies have been instructed by their supervising authorities that such measures cannot be used for initial audits. And as such, transfer from notified bodies that are stopping and well as move from MDD to MDR are both blocked, as these are regarded as initial audits. A solution is rapidly required!
Good news in this time is that the work of the MDCG largely continues, and the stream of guidance documents is continuing to flow. The face-to-face meetings have been replaced by teleconferences to not delay the work. And although communication becomes more focussed and sometimes edgy as we can all tell after a few weeks behind phone and screens…., there is much less time ‘wasted’ in travel etc. So if the atmosphere is right, more is accomplished this way.
That will even be further profited from if indeed EU Parliament and EU Council will agree to todays published delay of the Date of Application of the MDR; details see: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1585914772359&uri=COM:2020:144:FIN
Most recent guidance is on clarification for (medical) protective equipment, clarifying the situation around the Personal Protective Equipment (PPE: EU 2016/45) and Medical Devices (MDD/MDR). It addresses questions on conformity assessment, use of PPE and medical standards, and further guides to national measures on specified testing protocols, i.e. in Spain, Netherlands and South Germany (Bavaria). The guidance also clarifies medical masks to be self-declared under MDD/MDR, so not needing a Notified Body assessment (but registration, and if needed authorised representative), whilst PPE masks such as FFP2 are class III products requiring Notified Body assessment, with currently very scares testing capacity and waiting lists. The very useful guidance can be found here: https://ec.europa.eu/docsroom/documents/40521?locale=en
Should you need any support in understanding various exemption rules, applying them, or be in need of an authorised representative support, please understand at this moment we will prioritise COVID-19 product support.
For support, check out our website for regulatory, quality and clinical services as well as the growing availability of online training and (free) webinars.