Medical Device Regulation MDR – the experiment begins

Sometimes things happen whose effects only become fully apparent years later. This is exactly what happened on May 25, 2017. EU Regulation 2017/745 entered into force. The MDR replaces the MDD (93/42/EEC) and the AIMD (90/385/EEC). The IVD (98/79/EEC) is being merged into the IVDR. All of this is likely the result of the PIP breast implant scandal, in which a manufacturer used industrial-grade silicone instead of high-purity medical-grade silicone. The effects of the new MDR are gradually becoming apparent, although many question marks still remain for manufacturers and notified bodies. In this article, I would like to address the current status.

Why MDR?

Safety and efficacy are the basic requirements for a medical device. And only safe and effective products can be certified as compliant. This will not change in the future. The MDR aims to provide clearer specifications and increase the transparency of the requirements. The procedures of the regulatory and testing bodies are also to be more uniform. There will be stricter controls before and after the product is placed on the market. Traceability of products on the market is to be improved, and the public is provided with better information. These and other reasons are ultimately intended to lead to greater patient protection.

Structure of the MDR

The MDR is divided into 10 chapters and is completely restructured compared to the MDD.

1. Chapter: Scope and definitions
2. Chapter: Requirements for manufacturers, distributors and member states: Conformity assessment procedures, labeling, post-market clinical follow-up, post-market surveillance and much more
3. Chapter: Traceability of products, especially UDI
4. Chapter: Requirements for notified bodies
5. Chapter: Classification and Conformity Assessment
6. Chapter: Clinical evaluations and clinical trials
7. Chapter: Market surveillance, reporting
8. Chapter: Cooperation between Member States, the Medical Device Coordination Group and other experts
9. Chapter: Confidentiality, data protection, penalties
10. Chapter: Transitional periods and more

Even more interesting, however, are the appendices, which are spread across 17 chapters.

1. General safety and performance requirements
2. Technical documentation
3. Technical documentation on post-market surveillance
4. EU declaration of conformity
5. CE marking for conformity
6. Information to be submitted with the registration of devices and economic operators (UDI)
7. Requirements to be met by notified bodies
8. Classification criteria
9. Conformity assessment based on a quality management system and assessment of the technical documentation
10. Conformity assessment based on type examination
11. Conformity assessment based on product conformity verification
12. Procedure for custom-made devices
13. Certificates issued by a notified body
14. Clinical evaluation and PMCF
15. Clinical investigations
16. List of groups of products without an intended medical purpose
17. Correlation table

You can download the MDR free of charge:

MDR in English

MDR in German

What are Common Specifications?

Until now, harmonized standards were the means of choice for demonstrating conformity. In addition to standards, there will also be "Common Specifications" in the future, which the EU Commission will issue when it deems harmonized standards lacking or inadequate. These common specifications specify a series of technical and/or clinical requirements that must be met in addition to the standards. This will somewhat slow down the standards bodies and limit their authority. This may result in new requirements for manufacturers.

Implementing Acts and Guidances

Further requirements arise from European Implementing Acts and Implementing Guidelines, which can be published very quickly and are immediately effective. This obligates manufacturers to continuously check for new requirements that must be met. Countries themselves can also adopt so-called National Implementing Acts.

What about software?

Rule 11 of the MDR states: Software intended to provide information used to make decisions for diagnostic purposes belongs to Class IIa, unless those decisions have effects that may cause:

• the death or irreversible deterioration of a person’s state of health; in this case, he or she shall be classified in Class III, or
• a serious deterioration in health or surgical intervention; in this case, it is classified as Class IIb.

This means that, with a few exceptions such as KIS/HIS, RIS/Pacs datastores, there will hardly be any Class I software left.

What else should I consider?

• The classification of medical devices must be urgently reviewed. Anyone who previously owned a Class I or IIa/b device will quickly find themselves in a higher product class. For example, active therapeutic devices with diagnostic functions or closed-loop control systems, such as automated external defibrillators, will be classified as Class III devices instead of IIb in the future. The classification of software will become more stringent.
• The documentation requirements for medical devices are newly and detailed in Annex II. This may result in additional documentation costs.
• In the future, the EUDAMED database will consolidate a large amount of information in one place. This will open up new possibilities for regulatory authorities. If a manufacturer's medical device fails frequently due to a problem, the manufacturer may be contacted directly.
• In the future, every product will contain a unique identifier, the so-called UDI (unique device identification).
• In the future, companies will need a responsible person who has qualified expertise.
• Clinical evaluations and clinical trials will be regulated in much greater detail. This will result in additional costs for manufacturers. All manufacturers should, if possible, collect data from the field (post-market surveillance) and incorporate it into clinical evaluations. Those who don't yet have data should act quickly.
• For high-risk devices, the notified bodies should involve a committee of experts (the Medical Device Coordination Group (MDCG)) in the so-called scrutiny procedure. These experts can then provide scientific advice regarding the device's safety and performance.
• Reprocessing of single-use products is more strictly regulated.
• The previous PLM/OEM designs are no longer accepted in this form.
• Traders, importers and other economic actors will be held to significantly greater account.
• There are changes to the conformity assessment procedure that must be observed.

schedule

The table lists the most important dates and gives an overview of the schedule.

So what should we do now?

Three years go by quickly, so it's important to get started quickly. The best way to prepare for the new MDR is to set up a project and define a team.

Steps can look like this:

1. Creation of a project plan and scheduling of resources
2. Training of the project team on the new MDR
3. Review of existing product classification
4. Determining which products should be discontinued or continued to be distributed
5. Updating the technical documentation (especially clinical evaluation reports / PMS)
6. Introduce UDI
7. Appoint and train responsible person(s)
8. Conclude new contracts with dealers
9. Update QMS
10. Collect PMCF data

Also, talk to your notified body. Of the current 55 notified bodies, certainly not all will become the new notified bodies under the MDR. Experts expect some changes here. However, the impact of the new MDR will affect not only the notified bodies but also, in particular, manufacturers and distributors. Large corporations will be able to cope with the new guidelines much more easily than small and medium-sized enterprises. No one yet knows how this experiment will turn out. Of the approximately 500,000 medical devices, none yet has a CE mark according to the MDR.

Best regards

Goran Madzar