Tarek Elneil I believe that the requirements apply to key personnel involved in Manufacturing and Quality. This one person requirements depend on the organizational size, this might be the plant owner or plant manager who possesses expert knowledge of medical Devices. The basic FDA requirements that all personnel involved in the device Manufacturing or Quality must be qualified to perform their job that would include education, training and experience.

Marcelo Antunes It seems this text comes from the proposed MDR from Europe. The current text reads:

Person responsible for regulatory compliance
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Julie Omohundro As for the definition in the MDR, my cynical side says that this requirement was probably a pander to the unholy trinity of employers, recruiters and "degree-granting institutions." It reads like it was lifted verbatim from a job ad, doesn't it?

Julie Omohundro This term is used in a number of different contexts, so that anyone using the term should define what they mean by it. If it is in the proposed MDR, it's probably a "bleed over" from the pharma Directive (2001/83/EC). There it refers to someone who certifies that a batch of medicinal product meets requirements, so only the term was picked up from the pharma Directive, not its meaning.

Dr Kalina Tonigold Marcelo, thanks for the additional info.I'm in no position to disagree with this statement but my question wasn't "guess from where i got this text". I wanted to hear different opinions from the people from industry who are having such employed people and which kind of activities are their daily tasks.
"Person responsible for regulatory compliance" is it the same like QP?
Cheers

Marcelo Antunes The only texts that I know that mentioned a "qualified person" for medical devices were older versions of the draft MDR. The most recent text do not mention a "qualified person"anymore. That's why I think it's important to know where the text come from: if, again, the text is from the draft MDR, no one in industry is "having such employed people and which kind of activities are their daily tasks", because it's in the draft regulation which is still not in force and there's no other specific requirement such as this anywhere else, AFAIK.

Dr Kalina Tonigold Hi Macelo, my commend somehow disappeared. However, wanted to tell you that i appreciate your reply and i found it very helpful and in details. Thanks a lot.
I am in the end of my additional education for "Manager RA" (TÜV, Germany) and of course slowly i have started looking for a job. The text above is a part of a job offer (partially).
So i was just thinking "loudly" whether this profile might fit with my knowledge and experience.
Cheers

Michel ULSAS By the way, I was one "qualified person" in my former Company. Fortunately, never had to declare any adverse effect for MD or CE.

Michel ULSAS Hi everyone, reading your comments, I see quality oriented comments and but side of the question is not mentioned. It's materiovigilance. This looks and sounds like pharmacovigilance for drugs and that's what it is.
Basically manufacturer's (distributor's too) of Class II & III DM and equipment's should have someone in their structure capable of receiving, managing and declaring to health authorities any side-effects or adverse event and start relevant process of quality improvement if required, batch recall and all the safety issues.
I don't know yet if it's already mandatory everywhere... it is in France.

As Marcelo mentioned, the "QP" reference came from the original draft of the new European MDD but was dropped in favour of the tongue-twisting RPRC designation (responsible person for regulatory compliance) in order to avoid confusion with the pharma QP since they are 2 different roles (although there is nothing to stop one person being both a QP for pharma and an RPRC for medical devices if the training, experience and qualification component can be demonstrated for both!). I tend to disagree with Julie O's dismissal of the need for the designation as "cooked-up" - one must remember where the new MDR revision has its roots in - the PIP French scandal where the QA Manager releasing the batches of implantable devices was an ex-pastry cook with very little in the way of scientific knowledge. Never again!

Marcelo Antunes Nope. The new requirement for the MDR does not focus only in vigilance, but in compliance with the full regulatory requirements. Basically, it's someone which is responsible for full compliance with the MDR (and all other regulations). That's a bit different in scope than current requirements related to vigilance only.

i think professional knowledge in the products being dealt including regulatory affairs

Julie Omohundro Adrian, it's not the designation, but the qualifications that read like they were lifted verbatim from a job ad. Obviously the designation was not "cooked up" for the MDR, as it has been around for a long time already.

Stephen Griffin I believe the intent of the QP is to prevent a garage operation from cloning devices without an understanding of the materials issues (interactions of materials, stability in sterilization and storage, biocompatibility, etc.), the performance issues (mechanical, electrical, optical, biologic), the safety issues (risk analysis, statistics, validation, verification), etc. While I am the qualified person for my company -- having designed devices for some 30-years, with education in microbiology, analytical and biochemistry, materials science and electronics technology (and I can drive a tank, but that's never been required ;-), we have additional qualified persons to fill any gaps.

My concern and confusion has been with the clinical expert who, in my reading of the requirement, seems to be called upon to evaluate far more than clinical appropriateness for a device...any comments on that?

Michel ULSAS Marcelo I do agree with you, never said that all is about vigilance, but vigilance is part of it and no one was mentioning it.

Julie Omohundro Michel, Marcelo, I think the point of confusion is "This looks and sounds like pharmacovigilance for drugs and that's what it is." I think Michel meant "materiovigilance" by "This," but it can also be interpreted to refer to the QP requirement.

Glad to see the QP reference has been removed. Avoids confusion with Pharma.

Beluh Mabasa Ginting I believe that Quality Person (QP) in the field of medical devices and IVD medical devices must familiar with live cycle of each medical devices/IVD especially risk management files, regulation, medical devices classification and rule ,standards. My big question is...should QP in the field of medical devices/IVD must be certified..?

Julie Omohundro Stephen Griffin Could you clarify exactly which requirement you are reading? ("in my reading of the requirement")

"Qualified Person" is a term used in the EU phamarceutical regulation. It is a misuse of language in the scope of medical device, but generally used and understood, by comparison with the pharmaceutical industry. The equivalent in the medical device would be the Person responsible for regulatory compliance (PRRC), described Article 13 of the MDR (http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52012PC0542).

Julie Omohundro Beluh Mabassa Ginting, certification and other paper credentials sound good in theory.

In practice, they eventually turn professionals into commodities, as recruiters and HR screen on the credentials in lieu of assessing actual qualifications, largely because they don't know what those are. In theory, the hiring manager assesses those, but the hiring manager doesn't always know, either, especially in smaller companies. Regardless, some truly qualified candidates without credentials will be screened out, while some people who have "book learning" skills that don't necessarily transfer to hands-on skills, will get screened in.

Paper credentials also create an opportunity for people to make money conferring them. This soon leads to credentials being conferred on a certain number of people whose primary qualification is that they can pay for them.

Dr Kalina Tonigold Hi Julie Omohundro, certainly the best is both - substantial background and theoretical knowledge coming from certifications and credentials paired together with hands-on experience. Both are necessary. Same as for a company, which might have an outstanding quality management, but which is, however, not ISO certified. In the hiring manager’s or HR person’s eyes, these certificates might well express the same like an ISO certificate does for a company.
I started this topic to navigate around the requirements and needed certificates for a QP in medical devices. I’m looking forward to hear about the experience of other people which certificates and credentials would be the expected substantial background and theoretical knowledge for a QP in medical devices.

Marie-Catherine SARCIAUX As far as we have had discussion on this topic in France, that means a person with skill in medical devices to assume the responsibility of the medical devices on the concerned markets , it could be somebody from various functions QA or RA.... Knowledge of régulations, standards are necessary but background of practices is also useful.
The most important is to have a full access and overview of the key processes of the company and in the meantime sufficient knowledge about the process of the concerned medical devices. I thank this QP will be helpful to follow the com pliance of the described activities ( juste above).

Julie Omohundro Dr KT, as point of clarification, substantial background and theoretical knowledge do not come from certifications and credentials, but from education. It is quite possible to have education without certifications and credentials, certifications and credentials without education, and both together.

Marie-Catherine SARCIAUX Exactly!

This is tough question

I believe a Qualified Person in this contest means someone who possess technical and regulatory competence (Knowledge,qualification,experience and skills) and able to monitor,control and implement required standard in terms of QC/QA of goods and various SOP's during medical devices manufacturing process,distribution and if required during traceability issues in an organisation.

Hi All
The Qualified Person (QP) is position in pharma industry. According new MDR we have this below Article:
Article 13 - Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

The rest of info you find in Article 13 MDR :-)

My concern is that QP means the person who was handling with competency of their task and deliver the output in a particular time,it would be applicable for any industry like technical support of medical devices,sales and