Approval of Class I Medical Devices

What are Medical Devices?

Simply put, medical devices are products that fulfill a medical purpose and primarily act physically to perform their function. To precisely determine whether a given case involves a medical device, the definition must be checked:

“Medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for human beings for the purpose of one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • obtaining information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations

…and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
The following products are also considered medical devices:

  • Products for the control or support of conception.
  • Products specifically intended for the cleaning, disinfection or sterilisation of the products referred to in Article 1(4) and of the products referred to in paragraph 1 of this indent.

What Does Class I Mean?

Medical devices are classified into Classes I, IIa, IIb, and III. The lowest class (1 or I) is for products with low risk to patients. The higher the risk class, the higher the inherent risk of the respective medical device.

Admittedly, some medical devices are classified under the MDR into risk classes that may seem somewhat exaggerated. However, nothing can be changed about this – all classification rules of the MDR must be strictly observed. Thus, the highest risk class resulting from the application of all classification rules determines the actual risk class of a product.

Which Medical Devices are in Class I?

  • Walkers and many other aids
  • Plasters and compresses
  • Physical therapy tables
  • Reusable Surgical Instruments
  • etc.

What are the Deadlines?

Class I medical devices must meet the MDR requirements by the following deadlines:

  • Medical devices that were Class I under MDD (93/42/EEC) and remain Class I under MDR (EU 2017/745) must comply with the MDR since May 26, 2021.
  • Medical devices that were Class I under MDD (93/42/EEC) and are reclassified to a higher class under MDR (EU 2017/745) have longer transition periods. This is intended to account for the significantly increased effort due to the involvement of a notified body. Placing on the market is permitted until May 26, 2024.
  • Medical devices that fell under MDD (93/42/EEC) into Class Ir, Im, Is, IIa, IIb, III have different deadlines. However, we will not cover these in this article.

Note: Should a different deadline than May 26, 2021, apply in your case, your quality management system must still meet the minimum legal requirements since May 26, 2021!

What Does it Mean to be a Manufacturer?
Example of a Class I Medical Device

There are different ways the role of a medical device manufacturer can be defined. Nevertheless, they all have one thing in common: the company that acts as a medical device manufacturer in a legal sense has all the rights and obligations of a manufacturer. In particular, Article 10 of the MDR (EU 2017/745) on the general obligations of manufacturers must be observed. However, there are also aspects of product liability that are relevant.

Scenario 1 – I manufacture medical devices myself: The production of medical devices takes place within my own company. Accordingly, I bear full responsibility for what happens in production.

Scenario 2 – I do not manufacture medical devices myself: The production of medical devices is carried out by a subcontractor. Within the scope of their contractual obligation, they are thus responsible for the services they provide. However, it is important to note that as the manufacturer in a legal sense, you still bear the ultimate responsibility for what happens in production. You are the one placing the medical devices on the market, and you are responsible for ensuring that these products are MDR-compliant. So, you are merely outsourcing production, but never responsibility!

Scenario 3 – Hybrid of Scenario 1 and 2: Some manufacturers have a broader portfolio and produce both internally and with subcontractors. Naturally, you are also fully responsible for all products placed on the market by you in this case.

Outsourcing Production and Procurement of Raw Materials

It often happens that manufacturers have outsourced production and, at the same time, the procurement of necessary raw materials to a subcontractor. Unfortunately, it also often happens that the responsibility for product quality and conformity is assumed to lie with the subcontractor. However, this is not permissible.

You can, of course, outsource the process of production and raw material procurement. However, as already described in Scenarios 1 to 3, the responsibility remains with you. In any case, you must sufficiently monitor internal and outsourced processes to ensure compliance with regulatory requirements.

In the case of outsourced production, this means that you must review and approve the manufacturing processes. Production must only occur according to the agreed procedures. And you must verify compliance, for example, through audits and batch releases. In any case, you should conclude a QAA (Quality Assurance Agreement). This is a contract with the subcontractor that clearly defines the respective rights and obligations of both parties. Such a contract also protects you in case of subcontractor errors. Therefore, it is truly in your interest to conclude QAAs. A recall can quickly lead to costs in the six-figure range.

If a subcontractor takes over the procurement of raw materials for production, you must also agree on the necessary incoming goods inspections and other in-process controls. As stated: you outsource procurement, not responsibility.

Please note the following rule of thumb:

You must monitor and control outsourced processes at least to the same extent as internal processes. You outsource processes, not the responsibility of the medical device manufacturer!

How to Comply with the MDR?

Fundamentally, Article 10 of the MDR, titled “General Obligations of Manufacturers,” provides a good overview of what needs to be done. We present this in a more digestible way in the following text. However, you should generally note that all of the following points must be fulfilled. It is not sufficient for a legal state if only some of the points are met.

Quality Management System

As a manufacturer with only Class I medical devices in your portfolio, you need a quality management system that meets the minimum legal requirements. It is very important to note that such a QMS does not have to be certified according to ISO 9001 or ISO 13485 – but it can be!

This note is particularly important for small manufacturers and start-ups who are just venturing into medical technology with a Class I product. Implementing and maintaining a certified QMS is significantly more complex than merely covering the minimum legal requirements.

But even if you want or can take the less demanding path – keep in mind that operating a QM system runs parallel to daily work. This means you should budget a certain amount of effort for it. QM is not something you document at the end of the year and then consider yourself safe.

A functioning QM system is the foundation for your business model to be permanently legal and viable!

A QM system based on minimum legal requirements is a system that enables you to participate in medical technology and the European Union. You therefore have documented processes that provide clear guidelines on how to handle, for example, complaints. Because every complaint must be reviewed by you as the manufacturer to determine whether it constitutes a so-called “serious incident.” You would then have to report this to your local competent authority.

If you don’t know what such a “serious incident” is: this is also clearly described in processes. Thus, the QM system enables you to act correctly as a medical device manufacturer. You are able to react to events in a legally compliant manner and can thereby make the legally required contribution to the safety of individuals, and especially patients.

In principle, you can therefore imagine the QM system as enabling a company to behave like a medical device manufacturer.

Technical Documentation

The technical documentation is created per product. This is essentially a product file that must contain evidence that the product meets the legal requirements.

Note:
Summaries of technical documentation are not described for simplicity.

The legal requirements for products are primarily described in the so-called “General Safety and Performance Requirements” in Annex I of the MDR. Therefore, it must be checked for each product which of these requirements are applicable. Compliance with all applicable requirements must be demonstrated. This means: Documents are necessary for this. Things like “that’s how it’s always been” or “the product has been on the market for 20 years” are not permissible evidence within the meaning of EU 2017/745.

In addition to the product requirements, the technical documentation must provide certain minimum content. Annexes II and III of the MDR describe what needs to be prepared for this. It is important to note that all this content varies greatly between different products and manufacturers.

As we are often asked:

Other important components of the technical documentation include detailed information about manufacturing. Manufacturing must be truly traceable, and it must be clear where manufacturing takes place. This also includes all details on quality controls or in-process controls and batch release.

For each raw material / component / packaging, the respective supplier must be identifiable. You therefore need a fully traceable, documented chain from raw material to the actual medical device. All materials, all involved parties, and all work steps must be traceable.

The following graphic shows an exemplary structure of technical documentation as specified by the notified body DQS. Clicking on the image opens the linked PDF, giving you insight into the respective subfolders of the technical documentation.

You can download the template for free here.

Of course, the non-applicable chapters for your Class I medical device can be removed from the structure. Nevertheless, in our opinion, it is a good, because complete, example of technical documentation for a wide variety of products.

For all those who are now worried: We are well-versed in this and are happy to help create the necessary evidence.

Creation of an EU Declaration of Conformity

In the EU Declaration of Conformity, you, as the manufacturer, confirm that the product complies with the MDR requirements. This is essentially the approval as a Class I medical device. You do not need a certification body or authority for this. However, it must be said that the issuance is not legal if the product does not meet the requirements. Regulatory authorities regularly check manufacturers who newly register in DMIDS or EUDAMED (more on this later). Therefore, it is advisable to issue the Declaration of Conformity only if the technical documentation for the product is available and you have a QMS.

The EU Declaration of Conformity must contain the points mentioned in Annex IV of the MDR. The following image shows the excerpt from Annex IV of the MDR.

The SRN is the Single Registration Number that you receive when registering in EUDAMED. As of today (December 22, 2022), the use of EUDAMED is still voluntary because the database is not fully functional. Therefore, you may be able to issue the EU DoC (EU Declaration of Conformity) for quite some time without an SRN.

The Basic UDI-DI is a unique number that allows for the assignment of a product to you as the manufacturer. This is not to be confused with the UDI-DI (e.g., GTIN) and the UDI-DI (e.g., batch number + expiry date).

Registering in DMIDS

DMIDS is the system currently used in Germany for medical device manufacturers to register with local authorities. Medical devices that you distribute as a manufacturer are also registered there. The use of DMIDS is currently legally required.

There is another database or system at the European level called EUDAMED. However, EUDAMED is not yet fully functional, and therefore, it is not yet legally required to register products with EUDAMED. The registration of products in EUDAMED is currently voluntary.

Maintenance of Technical Documentation

Your QMS should describe in detail how the technical documentation (TD) can be continuously maintained. This is because the TD is not merely created once initially and then remains valid forever.

It is legally necessary to carry out so-called post-market surveillance. More on this here. The manufacturer checks whether their own product behaves as it should in the market. It is therefore checked whether the product causes any problems regarding safety or performance in the market. The insights gained from this are stored in the technical documentation.

Risk management must also be continuously updated. For example, if you receive a complaint that reveals a risk or product issue not yet considered in the risk analysis, you must address it and update the risk management file.

Also, every change to the product design, labels, or instructions for use – everything must be updated in the technical documentation so that it always reflects the current status.

Local Regulatory Authority & Inspections – Help! What Now?

Has your local regulatory authority announced an inspection and you are concerned that your technical documentation / QM system may not be sufficient?

Has your local regulatory authority already formulated deviations and set a deadline by which you must rectify them?

Please contact us promptly so that a timely response is possible. Together, we will find a solution!

Classification Dispute: My Product is Class I – the Local Authority Sees it Differently.

In this case, a decision by the BfArM may be necessary. The BfArM states the following on its website:

“For a demarcation or classification decision by the BfArM, an informal application for classification and/or demarcation must be submitted to the BfArM in accordance with § 6 para. 2 MPDG. In principle, a German Notified Body, the manufacturer, or the competent state authority are entitled to apply.”

Experience shows that there are often discrepancies regarding the classification of Class I medical devices, especially when it comes to software.

There is a widespread belief that software as Class I under MDR is virtually impossible. However, this is not true. Rule 11 of the MDR clearly describes when software can fall into Class I. The rule also clearly describes what software must not do if one wants to classify it as Class I.

Admittedly, the possibilities for such software in Class I are limited. But they exist. And that’s a good thing. Unfortunately, some local authorities see it differently – but in these cases, it is advisable to ensure legal certainty by applying to the BfArM.