Embarrassing Europe, an MDCG to Scold Manufacturers

“Note to manufacturers to ensure timely compliance with MDR requirements”. This is the title of MDCG 2022-11, the latest guideline – which is not a guideline – published on the European Commission’s website. A series of words that no one felt the need for.

Five years have passed since the adoption of Regulation (EU) 2017/745 and the system is in the implementation phase, including the process for designating notified bodies, the publication and harmonization of standards, as well as the publication of guidelines to help economic operators with their duties.

To date, there are 30 notified bodies to issue CE certificates according to MDR. 40% fewer than those previously notified under the Directive. The updated list is available here.
Of these 30, the first notifications were issued starting from 2019 (2 years after the adoption of the Regulation) and only 17 obtained it before 2021.
Of the 30, 7 are Italian and all, except 1, obtained the notification only last year.

Today we have 17 harmonized standards to the Regulation and published in the Official Journal.
Those according to the Directive were 276.

A note of merit, however, for the guidelines. To accompany the Regulation which, compared to the Directive, has 166 more pages (228 versus 66), there are 101 documents to “assist” manufacturers and notified bodies.

Eudamed, the database around which the Regulation was built, was supposed to be fully operational by May 2021. Not only is it not, but the paragraphs of 34 articles that refer to it will not be mandatory for the 2 years following the date when it will be. Date, moreover, unknown.

The UDI issue is already mandatory, fortunately for 4 private companies, the only ones authorized in Europe to issue the codes. However, you don’t need to put it on all products. At the moment you buy it and keep it in a drawer. Also because Eudamed, where you should upload it, doesn’t work (at least not entirely).

Finally, there is no trace of the common specifications that should have been applied to devices that do not have a medical purpose.

At this stage, data collected by notified bodies, and presented to competent authorities in December 2021, show that almost 37% of manufacturers’ applications were rejected as incomplete, highlighting a general lack of preparation on their part. In April 2022, 75% of notified bodies indicated that over 50% of applications were deemed incomplete.

Since the total number of applications is not known, the data doesn’t make much sense.
In any case, it’s reasonable to think that a good part concerns products certified according to 93/42/EEC, products that – virtually – since 1993 (when the Directive came into force), have been deemed compliant and safe for marketing in the European market.
As of April 2022, due to unprepared manufacturers, half of them are no longer so.

It is noted that about 70% of MDD certificates will expire in 2024. Manufacturers must consider that notified bodies under MDR will not be able to handle all requests in the first months of 2024.

The 7 Italian notified bodies, from 2021 to May 2024, are managing:

1. The recertification of the entire device portfolio;
2. The certification of devices previously certified by bodies that will not obtain MDR notification;
3. Certifications of new medical devices.

We’re not talking about the first months of 2024, the overload was written and signed on day zero. Not for nothing, on average, the bodies indicate that the certification process can last up to 12 months from the delivery of the technical file. This, manufacturers know well.

Consequently, in order to ensure that devices continue to be placed on the market and to avoid shortages of medical devices, it is essential that manufacturers complete the transition to MDR as soon as possible.

The Regulation is clearly inconsistent with the operational capabilities of the companies involved, the timelines are consequently too tight, but at least now we have an MDCG that blames manufacturers in case medical devices should become scarce.

We work with many manufacturers, distributors and importers. We collaborate directly with notified bodies and have already obtained the first certificates according to MDR.
We have suggested to our clients when to start and the vast majority have done so, asking us for support for compliance with Regulation (EU) 2017/745 and the provision of training courses.
The difficulties are not related to unpreparedness, nor to lack of will. It seems absurd to have to remind that a manufacturer lives by selling their products.
The problem is the price too high in terms of economics, time and resources.

Thus, the common approach for entities and manufacturers has been to give up maintaining medical devices with niche markets in their catalog. Often for niche pathologies.
And this, unfortunately, is no longer just a business problem.

Bad Europe, very bad.