2 min reading time

As originally asked by Mara Caler.

Has anyone seen an updated Essential Requirements Checklist? I’ve heard that the new MDR will require significant updates to the ERC, and would like a head-start on getting our files in shape. Thanks for any suggestions.

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Dan O’Leary
President at Ombu Enterprises, LLC
The General Safety and Performance Requirements do not mention any specific harmonized standards. However, there are QMS and RMS requirements in various parts of the EU-MDR. No doubt, EN ISO 13485:2012, EN ISO 13485:2016, and EN ISO 14971:2012 will be replaced by versions that match the EU-MDR and EU-IVDR.

Beluh Mabasa Ginting
Section Head of Standardisation at Directorate of Supervision of Medical Devices and Household Health Ministry of Health
I believe that Essential Requirements or General Safety and Performance Requirements is not talking only or comply to ISO 13485 and ISO 14971 but the most important thing the manufacturers must could demontrate that they have complied the regulatory authority requirements especially for the developing countries such as ASEAN communities.

Karen Zhou, RAC (Global)
Regulatory Affairs Professional
The Essential Requirements have been renamed to General Safety and Performance Requirements (GSPRs). The list is also longer now because of the incorporation of active implantable devices.

Ee Bin Liew
Access-2-Healthcare’s Owner and Consultant
Do not underestimate the legal and the product liability aspects of the EU MDR. They are significant as well.

no grandfathering so everyone ‘starts over’

increased requirements for ARs and NBs, causing a large shortage and potentially a huge bottleneck for approvals.

apply as an NB, anyone? 🙂

Cheers,
Ee Bin

Henk-Jan Kuiper
Consultancy Borderline products: Pharmaceuticals | Medical Devices | Food Supplements | Biocides | Cosmetics.
The old Essential Requirements Checklist is a copy of Annex I in the MDD. The updated Essential Requirements Checklist should be a copy of Annex I of the MDR. The chapter is called General Safety and Performance Requirements. Copy, paste and align the texts as in the old ECR

Zachary Macht
Sr. Manager Regulatory Operations Labeling at Becton Dickinson
I’ve been working with a large medical device company for the past 7 months running a pilot for conversion to the EU MDR requirements.

It is not too early to begin your EU MDR journey, there are significant changes to the requirements and organizational impacts to be considered.

Feel free to reach out to me directly with questions.

Dan O’Leary
President at Ombu Enterprises, LLC
I have no doubt that both EN ISO 13485:2016 and EN ISO 14971:2012 will be replaced by new versions that align with the EU-MDR and IVDR. Implementing ISO 13485:2016 would be valuable as part of the concept of getting ahead of the workload. Just recognize the need for additional work based on the new EU version.

For risk management, I assume you comply with EN ISO 14971:2012. I believe that the new regulations will “undo” some of the content deviations. Again, there is enough information in the new regulations to perform a gap analysis on your risk management file, but I’d be nervous about closing any of the gaps because you might then be out of compliance with the MDD.

Sheikh Muneer Ahmad
Founder|Mentor|Entrepreneur|Consultant|Director|CEO
good

Shreya Chandrasekhar
Development Quality Engineer II at Abbott
Hello Mara, Thanks for asking this question. Great discussion. I definitely want to follow this discussion.

Eckhard Jokisch
ISO-13485:2016 Lead Auditor, QA/RA Outsourcing Expert,QA/RA Enthusiast
The MDR is challenging – no doubts. On the other hand it is a perfect situation to re-assess the whole QMS and maybe identify spots that can be handled smarter or need some kind of rework.
As the ISO-13485:2016 at some point in time be the one you need to comply with I recommend using the time before the MDR is set into power to update the QMS to ISO-13485:2016.
Yet we even don’t know if ISO-13485:2003/2012 will be regarded as “Common Standard” in view of the MDR – so update to 13485:2016 now.

Erik Hatlanek
Consultant principal chez MCH Management Conseil Hatlanek Sàrl
I wait for the official publication before action un technical files.

Antonin Cuc
Head of Dept. Health and Safety at work at Ministry for Labour and Social Affairs
Todays Technician Requirements are adequate for the Research and Development of MDD, but after Clinic test are protocoled “CE” Conformity Assessment, there are recommendation to respect the Product in void of Producer, technician conditions – for example to take the firm installing instruments, measurement…but in delivered in Boxes – it is not understandable for Providers Health care and medical staff without Technician education. The first “Certification and presentation the new Medical Devices” – it is after 4 Hours not to understandable for reeducation medical staff. The praxes in medical daily workflow are realized by users without independent Technical supervision. All fatal technical illegal medical mistakes are caused fatal Mass heavy injuring of patients, mostly with preliminary dying – namely by false Radiology, Orthopaedy….but the official results are “Patient Unhappy by respects of Lege artis of medical staff”. In CZ are dying yearly 40 thousands Patient illegally!

David Funnell
Owner Funnell Instruments
I was just doing some catch-up reading and can suggest you check out the December 2016 article in BoneZone “Building Your Bridge to the Island of ISO 13485:2016” by John Gagliardi.

Dan O’Leary
President at Ombu Enterprises, LLC
If it were me, I’d start now. The final version will not change much it at all, so you won’t waste effort. The bad news, it that you won’t which standards are harmonized (all of that will change) or if there would be any common specifications.

I have some concerns that Annex I will be the least of the effort. Expect changes in UDI, PMS, Clinical Evaluation, etc.

Mara Caler
Director, Regulatory Affairs
Thanks to you both. It sounds like your recommendations would be to wait until the final publication (in the event of changes), then create a new Checklist based on Annex I. I can see full-employment in my future!

Steve Kent
Retired at Home
From my previous comment, if you are concerned with IVDs as opposed to the MDR then you need Annex 1 in:

http://data.consilium.europa.eu/doc/document/ST-10618-2016-REV-1/en/pdf

Steve Kent
Retired at Home
The Essential Requirements will be replaced by ‘General safety and performance requirements’ in the new MDR. The most up to date version of the MDR can be found at:

http://data.consilium.europa.eu/doc/document/ST-11662-2016-INIT/en/pdf

The ‘General safety and performance requirements’ checklist can then be generated from Annex 1, to match the Essential Requirements in Annex 1 of the MDD 93/42/EEC. There are now 19 sections rather than the previous 13. This is what I have done i.e. producing a template. However, there may still be some minor changes before the eventual publication of the final MDR.

Dan O’Leary
President at Ombu Enterprises, LLC
The new EU-MDR will make significant changes in just about every aspect of medical devices with a CE Mark. For example, there are new requirements for UDI. The title of Annex I becomes “General Safety and Performance Requirements”, and it has major differences from the Essential Requirements in the MDD. In addition, Annex II titled “Technical documentation” set forth requirements for maintaining the documentation to support the CE Mark.

The final version is expected in the Official Journal in March or April. The final draft is available, and should be close enough to the official version to start work. You should be able to find it with a Google search.