Regulatory Affairs

1. European Medical Device Law

From May 26, 2021, the European Medical Device Regulation (MDR) must be applied on a mandatory basis. It replaces the Medical Devices Directive that was in force until then.

For manufacturers, the MDR results in significant new and extended requirements, these include:

• The requirements for the quality management system and technical documentation (Annex II) of the MDR have been significantly increased.
• Market surveillance has been reorganized with shorter reporting deadlines.
• The documentation effort is also characterized by an increased effort: Additional reports and documented plans are required, e.g. on the Post Market Surveillance Plan/Report (PMS), Post Market Clinical Follow-up Report (PMCF), Periodic Safety Update Report (PSUR), Clinical Evaluation Plan (CEP), Summary of Safety and Clinical Performance (SS&CP).
• There are also stricter requirements for the compilation of clinical data in the clinical evaluation: The equivalence consideration is made more difficult, the reference to comparative raw data is only possible with the consent of the competitor; for higher classified medical devices, clinical trials become mandatory.
• New labeling requirements in the form of symbols in accordance with DIN EN ISO 15223-1:2020-04 will be necessary.
• Medical devices must be provided with a unique device identifier (UDI). This will be introduced step by step (first for class III products, last for class I products).
• The OEM relationships previously practiced by many companies are now only possible if the supplier provides the medical device manufacturer with the complete technical documentation.
• Numerous products must be reclassified (mostly higher) under the MDR; in the dental sector, this applies in particular to products containing nanomaterials. The higher classification also applies to material medical devices, reusable surgical-invasive instruments and software.

2. Classification List of Dental Medical Devices

The Medical Device Regulation (MDR), which will be applicable from 26.05.2021, has resulted in numerous changes and innovations with regard to the classification of medical devices (in accordance with Annex VIII of the MDR).

The following classification list has been adapted by the manufacturers of dental medical devices to the new law and the new requirements.

3. 3D Printing

Modern manufacturing methods, including the 3D printing process, are increasingly being used in the dental industry to produce medical devices.

The legal implications for manufacturers resulting in particular from the European Medical Devices Regulation, EU 2017/745, are being dealt with intensively by the 3D Printing Working Group, which was founded in October 2016. This working group consists of more than 30 people from companies of manufacturers and associations of dentists and dental technicians

In February 2018, this group published its position paper on dealing with custom-made products.

4. Barcode/UDI

Manufacturers of medical devices must meet stringent requirements if they want to manufacture medical devices or to bring them into the market. With the start of application of the European Medical Device Regulation (MDR), further requirements such as product labeling, external and internal traceability, and product monitoring on the market must be met. In addition, quality management systems require complete control and tracking of medical devices on the part of suppliers.

Companies in the dental industry made an early effort to develop a system that would meet these requirements absolutely reliably and effectively. Since, due to the abundance of data to be processed, manual data entry would not have been able to provide the necessary security, it was obvious to resort to barcode systems that could guarantee these requirements quickly, securely and without errors.

The HIBC barcode not only fulfils all MDR requirements mentioned, it also has decisive advantages comparted to other barcodes for optimal use by manufacturers, dealers and users in clinics and practices. In the dental industry, more than 80% of companies use the HIBC barcode.

5. Nanotechnology

The members of the Nanotechnology Working Group have held numerous meetings to address the question of whether and to what extent nanoparticles can be released from dental products containing nanomaterials.

In order to clarify this question, they have spent a great deal of time and effort compiling the available data from scientific studies, including the significant literature, and have used this as the basis for an evaluation of their products.

The results have been published in a comprehensive position paper. The manufacturers concluded that no significant exposure to nanoparticles is to be expected.

In June 2022, the EU Commission published a new recommendation on the definition of nanomaterials. Since the effects on manufacturers were not foreseeable, the members of the dental working group Nanotechnology decided to summarise all new aspects and changes in a position paper. 

6. Cobalt

Cobalt is considered a substance that may only be used in a very restricted manner (concentration maximum 0.1% weight by weight) under the application of the European Medical Device Regulation (MDR).

In addition, manufacturers must provide specific justifications for the use of cobalt.
The manufacturers of cobalt-chromium alloys have worked out these justifications together.

These papers are available in English, French and German.

7. Dental Amalgam

The EU Mercury Regulation, Regulation (EU) 2017/852 of May 17, 2017, has been in force since 2018. The regulation implements the Minamata Convention on the reduction of global mercury consumption for the protection of the environment, adopted in 2013 under the umbrella of the United Nations, at the European level.

This also provides a framework for the handling of dental amalgam in the European Union. The main contents of the regulation are:

• restriction of use for risk groups,
• use of amalgam only in pre-dosed encapsulated form,
• obligation of dentists to use amalgam separators.

Since 2021, the EU is in the process of reviewing this mercury regulation. The Commission is conducting an impact assessment on whether a complete phase-out of amalgam may be possible either in 2025, 2027 or as late as 2030.

All stakeholders concerned are involved in the opinion making process.

8. Electronic instruction for use (eIFU)

In the EU the use of electronic instructions for use (eIFU) is limited to only a few specific devices, such as fixed installed medical devices or implantable medical devices, due to the corresponding regulation of the EU Commission from 2012. Due to the rapid progress of digitalization and for reasons of environmental protection and resource conservation, the medical technology associations believe that an expansion to significantly more medical devices is necessary in order to enable manufacturers, but also (at least professional) users, to have access to the digital achievements. The dental industry has therefore drawn up a comprehensive statement that focuses in particular on the advantages of an eIFU.

Despite these industry arguments, the EU Commission has maintained the limited use of eIFU in the current “Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021”. This means that instructions for use in a paper version are still required for many medical devices.
Irrespective of this, the medical technology associations will continue to advocate for an expansion of the eIFU to significantly more products in the future.

9. TPO

Diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide (TPO) is an organophosphorus substance widely used in the dental industry as a photoinitiator for manufacturing of various products. TPO is classified as toxic to reproduction cat. 1B. This means that the continued use of this substance in medical devices in concentrations greater than 0.1% by mass must be justified by individual manufacturers in accordance with Annex 1 No. 10.4.1 and 10.4.2 of the MDR.

Various dental manufacturers have analysed the potential exposure of TPO to patients, compared TPO with alternative substances and treatment methods, and performed a benefit-risk assessment in a joint initiative in accordance with Annex I No. 10.4.2 of the MDR. They conclude that the TPO-containing products under consideration are safe in practice when the specifications from the instructions for use are observed.