New Service Offer - MDR's Person Responsible for Regulatory Compliance

Ronen E

Problem Solver
Staff member
Moderator
#1
To anyone interested, I'm offering "micro and small enterprises" (see below) and EU Authorised Representatives (EU reps) the service of being "permanently and continuously at their disposal" as their "Person responsible for regulatory compliance".


Background

The new MDR (Regulation EU 2017/745) requires, in its Article 15 (text irrelevant to this offer omitted and relevant emphasis added):

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.

(...)

2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

(...)

6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. 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.
According to Recommendation 2003/361/EC (Annex Title I Article 2), Small and Micro Enterprises are defined:

...a small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million.
...a micro enterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million.
Full details about eligibility under those terms are available in Recommendation 2003/361/EC. I will be glad to assist any interested organisation with the analysis and determination of whether they qualify.


The offer

I am offering to engage with interested parties, on a contract basis, for ongoing provision of services as described above in item 3 (a) to (e) inclusive.

I have the requisite expertise for serving as the Person responsible for regulatory compliance, both on behalf of micro and small enterprises and of EU reps, since:

- I have a university degree in Engineering (mechanical); and
- I have (a lot) over 4 years of professional experience in regulatory affairs and in quality management systems relating to medical devices.

In general I envision provision of this (new) service by way of on-site review / audit and, as necessary, either on-site or off-site follow-up to close any identified gaps, for an annual fee (TBD). I believe that an annual cycle should suffice, however a semi-annual cycle can be considered according to the circumstances. In between site visits I will be available, continuously, for remote routine consultation concerning the scope above (item 3 (a) to (e)). Anyway, all details are open to negotiation.

Please send me a private message if interested.

Kind regards,
Ronen.
 
Last edited:
Elsmar Forum Sponsor

Edward Reesor

Trusted Information Resource
#2
I see this as an excellent service for the extremely small companies (if 'micro' is 10 people or less, I guess you'd call it 'nano' or even 'pico' if there was only one employee). I had a discussion with someone who worked with a NB and he mentioned that there are many single employee businesses who may get hammered with the new MDSAP, MDR and 13485:2016 requirements.

Best of luck assisting entrepreneurs getting through all of this.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
I see this as an excellent service for the extremely small companies (if 'micro' is 10 people or less, I guess you'd call it 'nano' or even 'pico' if there was only one employee). I had a discussion with someone who worked with a NB and he mentioned that there are many single employee businesses who may get hammered with the new MDSAP, MDR and 13485:2016 requirements.

Best of luck assisting entrepreneurs getting through all of this.
Thanks for the comment, I tend to agree that heavy regulaition is especially tough for such "nano" businesses. However, the MDR specifies in multiple locations that certain requirements apply proportionally to the size/nature of the organisation and/or the risk level and nature of the device. From what I've seen one-man-operations and very small businesses usually don't deal with extra-complex or extra-risky devices; rather they're usually class I or IIa devices.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Just a quick question - how are you interpreting the requirement to be '..continuously at their disposal'?
Hi Cuffern,

Sorry for the late response, but better late than never!...

My view of the above is embodied in the arrangement I offered:
[...] by way of on-site review / audit and, as necessary, either on-site or off-site follow-up to close any identified gaps, for an annual fee (TBD). I believe that an annual cycle should suffice, however a semi-annual cycle can be considered according to the circumstances. In between site visits I will be available, continuously, for remote routine consultation concerning the scope above (item 3 (a) to (e)).
I believe that the article was intentionally worded so as to support small businesses, in allowing them to outsource that function with minimal rigidity concerning the organizational arrangement (i.e. employment or otherwise) and the PRRC's physical location (please note that the MDR text is silent WRT the latter). While the MDR was in the making (years...), there was much talk about how increasing regulatory burden is gradually killing small enterprises, diversity and innovation in medical devices, and I think that at least for this aspect (PRRC) everyone involved should be commended for coming up with a solution that is somewhat flexible.
 
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