The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know

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The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know

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The Medical Device Regulation MDR replaces both, the Medical Device Directive (MDD, 93/42/EEC) and the Directive for Active Implantable Medical Devices (AIMDD).
This video gives an overview on the 5 most relevant changes the MDR introduces. These changes include
1. Conformity assessment procedures
2. Classification
3. Essential requirements - General safety and performance requirements
4. UDI & EUDAMED
5. Post-Market requirements
The Johner Institute helps medical device manufacturers to fast and easily navigate the approval processes, to fulfill the MDR requirements and to obtain the CE mark.
Complimentary consulting on www.johner-institute.com.

Пікірлер: 36

@mu.mj2 4 жыл бұрын

You are great . Thanks for this videos ... I am an Arab engineer learning English

@dranthonyojo 3 жыл бұрын

Great. You are great. Thanks for this video

@JohnerInstitut 3 жыл бұрын

Thank you very much, Anthony! :-)

@paragkale293 2 жыл бұрын

Way of presentation Excellent Sir Pls share same for IVDR 746

@dineshbhardwaj195 2 жыл бұрын

Thanks sir very useful informations.

@nersesderartinian293 3 жыл бұрын

Great explanation!! Thank you

@jalaluddin9484 3 жыл бұрын

Sir, Thanks indeed for medical devices comprehensive presentation. i want to ask question: whether healthcare simulation systems like #mentice endovascular simulator, #urosim urology simulator, #lapsim laparoscopy simulator etc also required MDR regulations for their production???

@JohnerInstitut 3 жыл бұрын

This depends on the intended use. If you want the users to use it to learn e.g. for education purposes, it is not a medical device. If you want it to be used in order to simulate and thereby train for a particular patient i.e. to improve the treatment or reduce risks, then this simulator is a medical device and must fulfill the MDR requirements.

@jalaluddin9484 3 жыл бұрын

@@JohnerInstitut clear now, thanks for explanation. stay blessed!

@john-nssm3262 5 жыл бұрын

Thanks, good overview

@saurabh5534 6 жыл бұрын

Well described. Could you please tell me about MDCG and how they are going to help manufacturer?

@christianjohner6981 4 жыл бұрын

MDCG's primary interest and responsibility is not to help manufacturers. It is a coordination group. The tasks of MDCG are laid out in MDR / IVDR.

@MrsOlga2012 4 жыл бұрын

Thanks for a great video! Could you further explain why it will be a disaster for startups & a killer of innovation ?

@christianjohner6981 4 жыл бұрын

The new classification enforces conformity assessment procedures that require the involvement of a notified body and a certification of the quality management system. This increases the efforts and costs distinctly and slows down market access. As better scrutiny might be beneficial for public health, but a lack of products isn't.

@giovannigualniera7035 5 жыл бұрын

Nice overview. What I see missing is the mapping between the Software as Medical Device and the Rule 11 of the MDR. If you have a product both in the European and U.S. market is now difficutl to understand e..g if you softare is class IIb or Class III. The unclear point is about the "death" or "irreversible" health state of the patient. This is not covered by SaMD... Do you have suggestions about?

@ChristianJohner 5 жыл бұрын

I totally agree, that the two markets have different requirements. Europe is internally discussing to adopt the IMDRF document and to map it to MDR classes (you can find a German description (use Google translate) here: www.johner-institut.de/blog/regulatory-affairs/mdr-regel-11/#aktuelles). So far the classification is purely based on severity -- and thereby not on risk which is ridiculous. The IMDRF approach at least would help to introduce the probability by the "proximity" to the patient.

@mokar0873 5 жыл бұрын

Are these 3 items considered as medical devices?: Milling machines for dentists? 3D printers? 3D dental scaners ( not Intra Oral) Resins for dentists? Otherwise how are they classified? Thank you so much

@medizinischesoftware 5 жыл бұрын

1. yes, 2. depends on intended use and application, 3. yes. For a classification I need more information and time.

@ceciliarourke5738 3 жыл бұрын

what do you think where to next for the medical device industry?

@JohnerInstitut 3 жыл бұрын

Dear Cecilia, Thank you for watching the video! I'm not quite sure, whether I understand your question. Are you asking what is the future of medical device regulations? Or are you interested in the implications of the regulations on the medical device industriy?

@waelmourad4379 5 жыл бұрын

can I get a hard copy for this presentation

@kumarseb2510 4 жыл бұрын

Could you please tell me, in MDR 2017/745, what does 745 indicates?

@JohnerInstitut 4 жыл бұрын

It is regulation number 745 the EU released that year. Number 746 was IVDR.

@kumarseb2510 4 жыл бұрын

@@JohnerInstitut got it... Thank you johner.. 🙏

@mariappans1910 4 жыл бұрын

thanks

@felixselva 4 жыл бұрын

could you tell me 42/EEC means?

@christianjohner6981 4 жыл бұрын

93/42/EEC ist the number of the EU Medical Device Directive (MDD)

@felixselva 4 жыл бұрын

@@christianjohner6981 93 in the sense -release date is 1993.will 42 give any definition like this.Isn't it?

@christianjohner6981 4 жыл бұрын

@@felixselva 93 is the year, 42 stands for the 42nd directive that year.

@felixselva 4 жыл бұрын

@@christianjohner6981 Thank a lot for your reply.one more query EEC means?

@christianjohner6981 4 жыл бұрын

@@felixselva en.wikipedia.org/wiki/European_Economic_Community

@morulaainc3518 5 жыл бұрын

Register medical device as per Indian regulatory body i.e. CDSCO(Central Drugs Standard Control Organization). More details visit : morulaa.com/registration-services/ CDSCO Guidelines, CDSCO Approval