This article will discuss three of the most significant regulatory changes that will affect you. We will also look at the new obligations that you must respect before the new regulation comes into force on May 26, 2021.

1. You should implement a QMS in proportion to the potential risk of the medical device.

2. You need a person responsible for regulatory compliance permanently available.

3. The MDR dispose of 22 new rules to determine the class of your medical device. For CPOs, most devices will remain in the same categories.

Introduction

Since 2012, European institutions have been working hard to establish a strict legal regime for medical devices sold in the European market. Although the MDD (medical device directive) had been transposed in all European countries, there were many uncertainties and inconsistencies, which awakened the need for a new, directly applicable instrument.

In this new European Regulation, the European Parliament wanted to meet several objectives to have a more secure environment for all market players.

The purpose of this article is not to give a definitive interpretation of the Regulation (EU) 2017/745. This article aims to create awareness on how you, the orthopaedic technician, can become MDR compliant.

1. The Obligation to Implement a QMS

QMS (quality management system) is defined “as a formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency continuously.”

Article 10 of the new MDR states that you shall “establish documents, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.”

The new Regulation also specifies which parts of the organisation the QMS should cover “The QMS shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of process procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.”

In its proposal for the Regulation, the European parliament also hinted at how you need to implement this QMS. The implementation should be in proportion to the potential risk of the medical device.

“The legal obligations of manufacturers are proportionate to the risk class of the devices they produce. For example, this means that even though all manufacturers should have a quality management system (QMS) in place to ensure that their products consistently meet the regulatory requirements, the QMS-related responsibilities are stricter for manufacturers of high-risk devices than for manufacturers of low-risk devices. Manufacturers of medical devices for an individual patient, so-called “custom-made’ devices’, must ensure that their devices are safe and perform as intended, but their regulatory burden remains low.”

As a result, the implementation needs to be aligned with the risk of the device. Depending on the medical device you sell on the European market, you must respect differentobligations.

2. The Obligation to Dedicate a Person Responsible for Regulatory Compliance

The new MDR regulation introduces, in article 15, a new actor necessary to be MDR compliant. It states, “Manufacturers should have at least one person in their organisation responsible for regulatory compliance who has the required medical device expertise.”

This measure is now compulsory, except for micro or small enterprises, which are not required to have the person responsible for regulatory compliance within their organisation. However, they must have a person responsible for regulatory compliance available to them permanently.

The person responsible for regulatory compliance should assume many responsibilities. This person must meet certain conditions to access this position and needs to be carefully chosen.

You can count on Spentys regulatory compliance team to help you in your MDR compliance process. The regulatory compliance team of Spentys has the necessary expertise to help you respect the new MDR regulation.

3. The New Medical Device Classifications and the New Custom-made Definition

New Europeans regulations often come with new rules that need to be implemented before a given deadline. Annex VIII of the MDR includes a new classification model for medical devices that must be respected in your MDR compliance process.

The MDR dispose of 22 new rules to determine the class of your medical device. It is true that for orthopaedic technicians, the new classification is quite similar to the old one. Most devices will still be categorised as Class I (low-risk).

Nevertheless, you should investigate the classification for each product with caution. Each type leads to other obligations that you must respect. A higher degree of risk leads to stricter rules of control for the patient’s well-being.

The most notable modification is a new definition of custom-made. The old definition in the Medical device directive: “ any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices.”

The new definition of the MDR is similar but the last sentence is replaced: “However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.”

The last part of this new definition about mass-produced devices using industrial manufacturing has us wondering about the situation of custom-made medical devices printed by the 3D printer. The new definition’s essential element is that a product that follows a written prescription no longer automatically falls under a custom-made device. 3D printing falls under the category of industrial manufacturing techniques. However, the critical part of the sentence is the fact that the device can’t be mass-produced. If for instance, you use the 3D printer to create off the shelf-like orthotics that can be used for different patients, this can no longer be considered custom-made.

The European institutions have not yet pronounced on this matter, but the future will tell us if this new definition affects the use of 3D printers for medical devices. Spentys has an MDR compliance team, which is informed of any modification or evolutions in the new MDR. Working with our team guarantees you to be aware of any MDR alterations and be compliant even with changing interpretations.

Conclusion

These changes will strongly affect your practice. Without accurate preparation to implement MDR in your organisation, you face the risk of suffering many penalties. First, it is essential to determine the breaches in your MDR compliance and see which documentation you can keep from the old MDD.

Secondly, it would be interesting to focus on the implementation of a QMS. We would suggest starting with the MDR transition as soon as possible to avoid any unnecessary future problems.

With Spentys, not only you are guaranteed to get MDR compliant medical devices. You can also benefit from help, advice and support to make your manufacturing and distribution processes MDR compliant.

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