The MDR predecessor - the MDD - divided the medical devices into four risk classes (I, IIa, IIb and III). According to the MDD, no certification was required for products classified in Class I. In terms of patient safety, the MDR provides for a new assignment to the risk classes for numerous products. Many products that did not have to be certified according to the MDD now require certification.

The capacities of the bodies notified for the certification are not sufficient for the large rush of new certifications and the conversion of the existing products to the requirements of the MDR. There are currently only 34 bodies authorized to certify across the EU. Only eight of them are in Germany.

The certification bodies can be found here.

In the article “Medical Devices Ordinance - what will change for dental laboratories?” we have already briefly outlined the tasks for dental laboratories. In the following, we will go into more detail on the points of documentation requirements and the introduction of a quality and risk management system.*

You meet the documentation obligation with a declaration of conformity in accordance with Annex XIII of the MDR. The following information must be included:

• Name and address of the manufacturer with all production sites
• Identification (name, acronym or numeric code) of the patient for whom the device was manufactured and the statement that the device is intended solely for that patient
• Name of the prescriber and, if applicable, name of the medical institution concerned
• Specific characteristics of the product
• Declaration that the product in question complies with the essential safety and performance requirements according to Annex I of the MDR and, if applicable, a reference to the essential safety and performance requirements that were not fully met and why they could not be met

In addition to the declaration of conformity, documentation of the design, manufacture and performance of the custom-made product is mandatory. The storage obligation is at least 10 years after the product has been placed on the market, and in the case of implantable products even at least 15 years.

Finally, batch traceability must be guaranteed. This can be implemented, for example, using batch and lot numbers on delivery notes.

A registration as a manufacturer and the registration of their products in the European medical device database EUDAMED is not intended for the manufacturers of custom-made products.

According to the MDR, the quality and risk management system must take the following points into account (according to the risk class and the type of product):

Quality management system according to Article 10 (9) of the MDR and ISO 13485:

• Regulatory compliance concept
• Fulfillment of the applicable essential safety and performance requirements from Annex I of the MDR
• Responsibility of management board
• Resource management including supplier management
• Risk management (details see below)
• Clinical evaluation and follow-up
• Manufacturing process
• Post-market surveillance system
• Communication with all stakeholders involved
• Vigilance
• Management of corrective and preventive actions
• Product improvement

Risk management system according to Annex I Chapter I (3) of the MDR and ISO 14971:

• Risk management plan for each product or each “family of products”
• Identification, analysis, assessment, elimination and control of risks
• Evaluation of the information obtained by implementing the system in the manufacturing phase
• These findings must be used to make adjustments in the manufacturing process
• Preparation of a safety report that includes the review and documentation of post-marketing experience

*This overview does not claim to be complete.

Compliance with the Medical Device Regulation should be randomly checked by the competent authorities and the notified bodies. First checks have already taken place.

Definitive information on penalties for non-compliance is not yet available.

MDR – extension of the transition periods?
And yet it moves – at least a little...

We mean the EU Commission. Last Friday they also finally recognized that it is - under the given conditions - mathematically impossible to certify by then the 23,000 MDD certificates for medical devices, which expire in May 2024 at the latest, under the MDR, if the capacity of the notified bodies allows just 7,000 changes in this period. (For comparison: By October 2022, just 1,990 MDR certificates had been issued).

The Commission is therefore planning to extend the transition periods to May 2027 or May 2028, depending on the risk classes of the products (provided that the products remain safe, no significant changes have been made to them and that the manufacturers have submitted an application for certification by May 2024 to their notifying body). A corresponding amendment to the law is to be introduced in the EU Parliament at the beginning of 2023. And must still be implemented administratively after its adoption. The manufacturers will therefore have to still be patient for the moment.

The extension of the deadline can only be a start anyway - the serious structural problems of the MDR are unfortunately not solved, but only postponed into the future. It is to be hoped that the EU Commission will soon have some enlightenment and act accordingly. We will definitely keep you updated!

Update: Current changes to the transitional provisions can be found in the article www.caddent.de/en/blog/mdr-update-0323