The media world is dominated by news about the COVID pandemic, with other reports sometimes disappearing into “lower drawers”. But this is no small matter for medical device manufacturers: The entry into force of the Medical Device Regulation, actually scheduled for 26 May 2020, is to be postponed by one year, EU Commissioner Stella Kyriakides announced last Wednesday. This still has to be approved in writing, which can be expected by the beginning of April.
For us, this means that projects starting from May 2020 are not yet covered by the new, stricter regulations. We – and our customers with their innovations – can continue to rely on the currently applicable laws one year longer.
Of course, this in no way means that we are getting lazy. If it were up to us, MDR could come tomorrow, we are fit – but experience shows that you can never be too prepared. Therefore, we are looking forward to continue to be diligent for our customers until the new start date (and of course beyond).
Although we still meet every day, transmission is not possible in our rooms: sterilising chemicals on the doors, no touching, interaction only at the recommended distance, no more sharing of objects. In this way we protect ourselves and our fellow human beings.
Does this mean that we are hampered in our work? Not at all.
In a situation that changes every hour, we have to think carefully about how to maintain our processes. It is not our way to panic, but acknowledging the seriousness of the situation, we have to be vigilant and keep a level head. Our goals stay the very same: To take good care of all our clients and to drive innovations forward for the ever-growing healthcare market. The current crisis takes strength from all of us, but it also makes us grow as a company. We try to go even faster: smoothing processes out, finding new modes of operation, working from different locations with more flexibility. Despite the severe circumstances, it is a challenge that we gladly accept.
We’ll be there for you – so you can be there for the patients.
As of 26 May 2020, in addition to the Medical Device Regulation (EU-MDR 2017/745), the requirements of the Medical Device Law Implementation Act (MPDG) are to apply – but so far, this is only available as a draft law. In Germany, it is to contribute, among other things, nationally valid implementation regulations and ultimately replace the MPG (Medical Device Law). For the so-called “other clinical trials”, this means a much more detailed regulation ... Fortunately, we at MEDIACC are fully conversant with this issue. We create innovations, including medical apps, together with key opinion leaders who have trusted us for many years – just like our customers!
It is no time for cinema, it is no time for a museum or going swimming, but it is certainly no time to stop working or to lose the joy of life. We support our customers flexibly in their joint projects and thank the German Federal Government for implementing the package of measures to support our economy in these days full of challenges and innovative solutions requiring our joint efforts.
We are pleased to hear that finally, German parliament regulated the implementation of the EU Medical Device Directive (MDR) into national medical device law with the resolution of the Medical Device Implementation Act (MPDG). It was high time for manufacturers and us as their partners who develop, test and make sure to deliver safe and innovative medical devices. The high standards of clinical research in Germany are maintained and patient safety will be strengthened. We will now be able to plan and set up future clinical trials beyond 26.5.2020. After final approval of the Federal Council the new regulations will immediately come into force.
Innovative medical devices that are so-called new examination and treatment method (NUB) according to § 137e SGB V and which have shown to be a potential required treatment alternative need to be tested within the framework of a testing guideline of the Federal Joint Committee (G-BA). Aim is to evaluate the medical benefit. In yesterday's press release, the G-BA publicly announced our next steps which will be submission of our study concept to the Federal Ministry of Health and to obtain the positive vote of the Ethics Committee. As independent scientific institution (UWI), we look forward to making our contribution to improve patient care and support companies to get their innovative products reimbursed in Germany.
Today, on 5 March 2020, the German Bundestag will finally vote on the draft bill to reform German medical device law, as it is to be adapted to EU requirements. The aim is to create a single EU market for medical devices with high quality and safety standards. For the BfArM (Federal Institute for Drugs and Medical Devices) and the PEI (Paul Ehrlich Institute) this would mean that they – instead of the state authorities – would take responsibility for excluding risky medical devices from the market. The counterfeiting of drugs and medical devices would also be made considerably more difficult.
Three motions by two parties on this issue will also be put to the vote, all three of which call for preventive or interception measures on possible weaknesses in the new laws. We are curious to see how it all turns out.
With the changes of the Medical Device Law Implementation Act (MPDG) draft, we are constantly discussing the impact of expected changes and increase of requirements amongst medical colleagues, clients and authorities, especially for former so-called “scientific studies”.
This new regulation specifies “other” clinical trials under Art. 82 (1) MDR (EU) 2017/745 and adds up to clinical trials under the German Medicines Act (AMG), clinical trials under Art. 62 (1) EU Medical Devices Directive (MDR (EU) 2017/745), and clinical trials on food supplements, cosmetics or similar.
We are now awaiting the adaptation of the new law that certainly by increasing needed qualifications and regulatory standards will make clinical studies more elaborate and expensive while increasing the safety and validity of data. We will keep you informed!
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