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Notified Body

MDC (Germany)

CE 0483

Reviews of MDC, a Notified Body in Germany

These are user-submitted reviews of medical device companies describing their experience working with this notified body. This includes how well-organized the notified body was, technical proficiency of the auditor, wait times and cost.

Important Notes

Notified bodies typically work with many different auditors, some of which are freelancers. That's one of many reasons which may lead to strongly varying reviews of the same notified body.

And lastly: Even though some reviews may be negative, the goal is not to rant about notified bodies. We've built this to facilitate the sharing of information between Healthcare companies. The goal is to improve Healthcare by helping everyone bring medical devices to market in a safe, predictable, affordable and fair way.

As manufacturers get to choose their notified body, these reviews should help companies choose one which is fair, well-organized and technically competent.

March 21st, 2022

Small Company (<10 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: pending

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

n/a
Overall experience
n/a
Well-organized / responsive
n/a
Regulatory pragmatism
n/a
Technical competence

Audit Stage

Reached out to learn about procedure.

Comment

Very friendly conversation, they accept new customers (are also obliged to do so), acceptance can of course still not be guaranteed, especially due to capacity in the much requested software area. Once we submit the TD, it takes 4-5 months to audit due to multiple runs until they are satisfied with it. Their experience is that the TD are usually not good enough for MDR, hence this process. They have no problem at all if we do the 13485 at BerlinCert, they prefer to take new customers who are already at a Notified Body as they are better prepared - it will just make higher costs for us due to two audits. For MDR we can expect around 20.000€ in the 1st year, their daily rate is 2.000€. He emphasized again that they are not allowed to do consulting and recommend an external consultant for that. In their experience, clients were more successful in moving from MDD to MDR if they didn't just do a gap analysis, but pretty much rebuilt the TD. mdc is focused on the mid-market, EU and Israel. We can submit a request via the download section, offer or rejection will probably come in September due to vacations.

February 28th, 2022

Mid-size Company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: 6 months

QMS Certificate: 2 months

Techdoc Audit: 5 months

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: yes

Audit Stage

Client since 10 years MDR TD and QMS in progress

Cost

30.000€

February 28th, 2022

Mid-size Company (10-49 employees)

qms audit in progress techdoc audit in progress

Wait times

QMS Audit: pending

QMS Certificate: pending

Techdoc Audit: pending

Techdoc Certificate: pending

Ratings

Overall experience
Well-organized / responsive
Regulatory pragmatism
Technical competence
Would choose again: no

Audit Stage

Clinical audit done, before rest of Tech audit and QMS audit. 4 months before clinical Audit, more than 3 months for the rest of the Tech-Audit (and still waiting). QMS Audit only planned if the clinical audit and a first positive report on the Tech Audit is performed.

Comment on Duration and Cost

No planification possible and further delayed are announced each 3 weeks.

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