Medical Device Regulation (MDR) – Regulation 2017/745 (EU) on Medical Devices
The German counterpart to the term “Medical Device Regulation” is “Medizinprodukteverordnung”. The regulation 2017/745 by the European Union (EU) will be enacted on May 26, 2021 across Europe. In this article provides you with information on the content and implementation regulations for the medical technology industry.
EU regulation tailored for the medical technology industry
The “Regulation (EU) 2017/745 of the European Parliament and of the Council concerning medical devices” was enacted already on 5 April 2017. It replaces the formerly applied “Directive 93/42/EEC concerning medical devices”. This actually means for the medical technology sector that the EU regulation 2017/745 substitutes for the following previous guidelines:
- Directive 93/42/EEC concerning medical devices (MDD);
- Directive 90/385/EWG, Active Implantable Medical Devices (AIMDD
The EU authorities agreed upon a separate regulation regarding the Directive 98/79/EU on in-vitro diagnostics (IVD). This directive was not included in the Medical Device Regulation. It is replaced by the separately drafted EU Regulation “In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
Binding from May 26, 2021 across Europe.
In contrast to the discontinued directive, the new EU parliament regulation has gained in international profile. Its binding validity extends to all EU Member States from 26 May 2021. It must be noted here that by October 2019, no national legislation has been passed in the individual member states. This also applies to German peculiarities, requirements and penal provisions to be enacted. A respective draft for a German implementing law already exists. However, the Federal Ministry of Health expects transitional periods.
According to the existing legal text, the a transition period of three years applies for the implementation. At the latest after this deadline, you as the manufacturer are obliged to present an MDR certificate. Only then you are allowed to market a product for the first time.
*In the wake of the COVID-19 pandemic, the effective date of the regulation was postponed to May 26, 2021.
Objective and necessity of the new EU regulation
Basically, the new regulation aims at an optimized, uniform regulation for the market launch of medical technology products. It focuses on the factors product safety and product quality. For you as a market participant and user, the new EU regulation provides a mix of known content from the previous Directive 93/42/EEC and far-reaching changes. For you and your industry, the following main content and procedural content of the Brussels regulation may be of interest:
Regulations on the classification of medical devices New terminology and regulations result in a changed association of existing products to partially changed product classes. For example, these changes affect the product range of “Stand-alone software”.
Conformity assessment procedure
According to the rules for the classification, the conformity assessment procedure now varies depending on the class.
Technical documentation/Document Management System
The technical documentation according to the Medical Device Regulation proves to be significantly more detailed. The benefits of supervision and documentation for companies are obvious after a detailed look at the new underlying schema in tabular form. The organization into individual categories with a direct reference to the related detailed requirements is a basis for a detailed technical documentation.
Discover the suitable software for MDR compliance
Clinical evaluations/clinical trials
This action point is subject to significantly increased requirements. This especially applies to high-risk product groups.
Corporate responsibility/Compliance Manager
A significant change for your company results from the EU authorities demanding a dedicated person in charge of compliance with regulatory requirements at your company.
The FDA Medical Device 21 CFR 820 (FDA = U.S. Food and Drug Administration) specifies the requirements for management systems of manufacturers of medical devices. In this function, the Device 21 CFR 820 is the counterpart to the ISO 13485. Its main requirement is that process instructions and document control, purchasing, development as well as the production must be documented and implemented equivalently.
Market surveillance mechanisms
Especially the mandatory use of the EUDAMED database creates greater transparency. It is available as a source of information to the public as well as for direct competitors. Using respective links, every medical device is displayed with its characteristics. This also allows to retrace supply chains.
How to comply with the Medical Device Regulation
In order to comply with the new regulation in time, you as the person in charge at your company must act. A plan with coherent schedule and content of the implementation of the Medical Device Regulation is the basis of your success. Your main priority should be the lifecycles of your portfolio of medical devices. According to the EU directive, the existing MDD approvals loose validity by May 26, 2024. Your planning should consider that your already existing MDD-certified products must be subject to the new conformity process to be established according to the MDR. A protection of the “grandfather status” is not guaranteed.
In the conversion phase, you are particularly challenged in your function as a manufacturer or supplier. Your highest priority should be identifying and training each person responsible for the compliance with regulatory directives in your company (MDR article 15). The quality assurance procedures and the documentation must be updated and the product classification must be modified.
Against this background, this standardized procedure according to the following 4 points is recommended:
- Implementing the evaluation of the conformity based on the product
- Creating the declaration of conformity
- “CE” marking of the products
- Entry of the company and its products in the EUDAMED database.
Conclusion and criticism of the new regulation
With MDR, the EU leaders have set out to create a modern, uniform solution for quality management and the market release of medical devices. It mainly focuses on the on the product quality and product safety. Maybe you as a small or medium-sized business in the medical device industry also fear to be over-regulated by the extensive set of rules and additional controlling authorities?
Especially the assessment of the conformity by the “compliance manager” to be named could result in a staffing issue, at first. I the worst case, a lack of certified supervisors could delay the approval required for the product launch. Industry associations in the medical technology sector express fears that a bottleneck in certification could have a negative impact on the market launch of innovative and marketable products.