TECHNICAL DOCUMENTATION SOFTWARE

The Medical Device Regulation (MDR) has been valid in the European Union (EU) since May 26, 2021. This article provides information on its content and the implementation provisions for the medical technology industry.

The “Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices” came into force on April 5, 2017. It replaces the previous “Directive 93/42/EEC on medical devices”. In concrete terms, this means that EU Regulation 2017/745 replaces the following previous directives in the field of medical technology:

• Medical Device Directive 93/42/EEC (MDD);
• Directive 90/385/EEC, active implantable medical devices – Active Implantable Medical Devices (AIMDD)

The EU bodies opted for a separate regulation in relation to Directive 98/79/EC on in vitro diagnostic medical devices (IVD). This directive has not been incorporated into the Medical Device Regulation. It will be replaced by the separately formulated EU regulation “In-vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)”.

In contrast to the superseded directive, the EU Parliament’s new regulation has gained international significance. Its binding validity extends to all EU member states from May 26, 2021. It should be noted that no national legal acts had been adopted by the individual member states by October 2019. This also applies to special German features, requirements and regulations to be issued. Although there is a corresponding draft for a German implementation law, the Federal Ministry of Health expects transitional periods.

According to the current legal text, a transitional period of three years (26.05.17 – 25.05.21*) applies for implementation. Manufacturers have been obliged to submit an MDR certificate since the deadline expired at the latest. This is the only way they are allowed to launch a product on the market for the first time.

*In the wake of the COVID 19 pandemic, the effective date of the regulation was delayed to May 26, 2021

At its core, the new regulation aims to provide optimised, uniform rules for the market launch of medical technology products. The focus here is on product safety and product quality. For market participants and users, the new EU regulation consists of a mixture of familiar content from the previous Directive 93/42/EEC and far-reaching innovations. The main substantive and procedural aspects for you and your sector include the following contents of the Brussels Regulation:

Rules for the classification of medical devices
New terms and rules lead to changes in the allocation of existing products to product classes, some of which have changed. The field of stand-alone software products, for example, is affected by these changes.

Conformity evaluation procedure
In line with the classification regulations, the conformity assessment procedure now also differs depending on the class.

Technical Documentation/Document Management System
Technical documentation in accordance with the Medical Device Regulation proves to be much more detailed. The advantages for companies in terms of control and documentation become clear when you look at the new underlying, tabularly structured scheme in detail. The subdivision into individual categories in direct connection with the associated detailed requirements forms the basis for detailed technical documentation.

Clinical evaluations/clinical verifications
This action point is characterised by significantly higher requirements. This applies in particular to high-risk product groups.

Company responsibility/safety officer
A significant change for your company results from the requirement of the EU bodies for a responsible person who is responsible for compliance with the regulatory requirements in your organisation.

Quality management
The FDA Medical Device 21 CFR 820 (FDA = U.S. Food and Drug Administration) stipulates the requirements for management systems of medical device manufacturers. In this function, Device 21 CFR 820 is a counterpart to ISO 13485. The core requirement is that procedural instructions such as document control, procurement, development and production are documented and implemented analogously.

Market surveillance mechanisms
In particular, the mandatory use of the EUDAMED database ensures greater transparency. It is available to both the public and direct competitors as an information medium. The characteristics of each medical device are mapped using appropriate links. Supply chain traceability is also possible.

In the interest of timely compliance with the new regulation, you are the responsible person in the company. A well-timed and coherent plan for your company’s transition to the Medical Device Regulation is a prerequisite for your success. You should give high priority to the life cycles of your medical device portfolio. Existing MDD certifications will lose their validity on May 26, 2024 in accordance with EU regulations. When planning, please bear in mind that your products already certified according to MDD must also undergo the new conformity procedure to be created according to MDR. Grandfathering is not guaranteed.

During the changeover phase, you are particularly challenged in your role as manufacturer or supplier. The top priority is to designate and train the person responsible for compliance in your company (MDR Article 15). Updates to internal quality assurance procedures, documentation and the amended product classification are mandatory.

Against this background, the following standardised procedure is recommended according to the following 4 points:

• Carrying out the conformity assessment in relation to the product
• Issuing the declaration of conformity
• “CE” marking of the products
• Registration of the company and products in the EUDAMED database.

With the MDR, the EU authorities have set out to create a modern, standardised solution for the Quality Management and market release of medical devices. Great attention is paid to the quality and safety of the products. Perhaps you are one of the small and medium-sized companies in the medical technology industry that fear over-regulation due to the extensive regulations and additional inspection bodies?

In particular, the assessment of conformity by the “compliance manager” to be hired is likely to become a personnel problem in the start-up phase. In the event of hardship, a shortage of certified inspectors could delay the certification required for market release. Medical technology industry associations are concerned that a bottleneck in certification could have a negative impact on the market launch of innovative and marketable products.