TECHNICAL DOCUMENTATION SOFTWARE

The Medical Device Regulation (MDR) has been in force in the European Union (EU) since 26 May 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 5 April 2017. It replaces the previous ‘Medical Devices Directive 93/42/EEC’. In concrete terms, this means that EU Regulation 2017/745 replaces the following previous directives in the field of medical technology:

• Directive 93/42/EEC concerning medical devices (MDD);
• Directive 90/385/EEC, active implantable medical devices (AIMDD).

The EU bodies decided in favour of a separate regulation in relation to Directive 98/79/EC on in vitro diagnostic medical devices (IVD). This directive was not incorporated into the Medical Devices Regulation. It has been replaced by the separately formulated EU regulation ‘In-vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)’.

In contrast to the superseded directive, the EU Parliament’s new regulation has gained international significance.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 26 May 2021. It should be noted that no national legislation had been adopted by the individual member states by October 2019. This also applies to German specifics, requirements and regulations to be issued. Although there is a corresponding draft for a German implementing 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 are obliged to submit an MDR certificate by the end of this period at the latest. This is the only way they are permitted to place a product on the market for the first time.

*In the course of the COVID-19 pandemic, the date of application of the regulation was postponed to 26 May 2021.

At its core, the new regulation aims to optimise and standardise regulations for the market launch of medical technology products. The focus 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 key content and procedural aspects for you and your industry 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 ‘stand-alone’ software product area, for example, is affected by these changes.

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

Technical documentation/document management system
The technical documentation in accordance with the Medical Devices Regulation is 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 trials
This action point is characterised by significantly increased requirements. This applies in particular to high-risk product groups.

Corporate responsibility/safety officer
A significant change for your company comes from the EU bodies’ requirement for a responsible person responsible for compliance with regulatory requirements in their organization.

Quality management
The FDA Medical Device 21 CFR 820 (FDA = U.S. Food and Drug Administration) formulates 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 more transparency. It is available as an information medium to both the public and direct competitors. The features of each medical device are mapped using appropriate links. It is also possible to trace supply chains

In the interest of timely compliance with the new regulation, you are the responsible person in the company. A consistent plan in terms of timing and content for converting your company to the Medical Devices Regulation is a prerequisite for your success. You should give high priority to the life cycles of your medical device portfolio. According to EU regulations, existing MDD certifications will no longer be valid on May 26, 2024. When planning, please keep in mind that your products that are already certified according to MDD must also go through the newly created conformity procedure according to MDR. Grandfathering is not guaranteed.

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

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

• Carrying out the conformity assessment regarding the product
• Issuance of 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, uniform solution for quality management and the market release of medical devices. Great attention is paid to the quality and safety of the products. Maybe you are one of the small and medium-sized companies in the medical technology industry who fear over-regulation due to the extensive set of rules and additional control 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 hardship cases, a lack of certified inspectors could delay the certification necessary for market release. Medical technology industry associations express the fear that a bottleneck in certifications could have a negative impact on the market launch of innovative and marketable products.