Share your experiences in connection with your notified organisation!

In order to make the regulation of medical devices more transparent, the OPENREGULATORY team wants to help companies choose the right notified body. Previously, companies have been reluctant to publicly share their experiences with notified bodies. They wanted to change this by providing a place where everyone can share their stories anonymously.

The website operators point out that although they have collected quite a number of opinions on several notified bodies, there is not a sufficient number of opinions on each notified body. It was therefore decided not to calculate an average rating for the time being.

In addition, notified bodies usually work with many different auditors, some of whom are freelance. This is one of many reasons that can lead to widely differing assessments for the same notified body.

And finally, while some opinions may be negative, the aim is not to criticise or discredit the organisations reported. The website was created to facilitate the sharing of information between medical device manufacturers. The aim is to improve healthcare by making it safe, predictable, affordable and fair for everyone to market their medical devices. Since manufacturers can choose their notified body, these reviews should help companies to choose a notified body that is fair, well organised and professionally competent.

Length of the conformity assessment procedure

In addition to the reviews, the editors of the site also requested more data from manufacturers. This gives a realistic picture of the time and cost of quality management system audit and certification, technical documentation review and certification.

At a previous point in time, we reviewed 24 reviews, which yielded the following results:

• Quality management system audit duration:
  • Average: 6,4 months
  • Dispersion: 2 – 18 months
• Quality management system certificate issue period:
  • Average: 3 months
  • Dispersion: 1 – 6 months
• Technical documentation review period:
  • Average: 6,5 months
  • Dispersion: 1 – 24 months
• Technical Documentation Certificate issue duration:
  • Average: 4,1 months
  • Dispersion: 1 – 18 months

Based on the above, the average length of an MDR conformity assessment procedure is 20 months. In practice, it is more like 16 - 18 months, as the next verification stage can be carried out in parallel with the certification of one stage. This value is in line with the 12 - 18 months previously reported by the notified bodies.

What follows from the above? If we count back 18 months from 26.05.2024, the application for conformity assessment must be submitted to the notified body no later than this autumn in order to have a chance of obtaining the certificate before the deadline.

Certification costs

It is difficult to track certification costs from the data as it is not always consistent which costs are reported by the registrar. In addition, certification costs are significantly dependent on the risk class, the number of technical documents, which is not known, and the size of the company. Most of the registrants are small companies (10 - 49 persons).

So the following data should be treated with strong reservations, but they do give some indication:

• Certification costs:
  • Average: 27.638 EUR
  • Dispersion: 10.000 - 50.000 EUR

Most common complaint

If you read the reviews a little bit, most of the complaints from manufacturers are about communication. There are several cases where notified bodies do not respond to enquiries and questions for months.

Share your experiences in connection with notified bodies so we can get a clearer picture: https://openregulatory.com/notified-bodies/