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EU Medical Device Regulation MDR 2017/745

EU Medical Device Regulation MDR 2017/745

Application for designation under the Medical Device Regulation (MDR) 2017/745

Medical Device Regulation (MDR) 2017/745

Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Medical Device Regulation (MDR) 2017/745. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.

Customer Survey for the conversion of your certificates

xlsx Customer survey MDR 50 KB Download

A head start on compliance with the new EU Medical Device Regulation

Recommendations for the new MDR 2017/745 | TÜV Rheinland
Our recommendations in relation to the MDR revision

Manufacturers of medical devices are facing new requirements with MDR 2017/745, which took effect May 25, 2017 with an application date of May 26, 2020. During the transition period, medical device manufacturers must plan, prepare and implement strategies for compliance, as this regulation is a prerequisite for access to European markets.

Our solid track record in the field of medical devices is underpinned by our solid reliability and extensive expertise. As a well established Notified Body, we have actively verified compliance under the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD), both of which are now being replaced by the new regulation. Our capacity and competence in the field is already in place and we look forward to sharing our knowledge with existing clients and new partners alike.

With our experience and solid status as a Notified Body under current legislation governing medical devices, we are perfectly positioned to support you in the transition to the new regulation .

Contact us to learn more about the specifics and timing of MDR 2017/745 and how it affects your business.

MDR audits ensure access to EU markets

With the replacement by MDR 2017/745 of existing rules governing medical devices in the EU, manufacturers will soon be required to reassess their products for compliance. An MDR conformity assessment procedure provides companies the chance of achieving the necessary certification required to place products on the European market. Compliance access, your prerequisite for regulatory success.

On your path to compliance we can inform and ultimately carry out any necessary technical documentation review and auditing. We are backed by a global network of industry experienced specialists and facilities and offer a one-stop shop of medical device-related services.

Medical device conformity assessment and beyond

Currently, our services focus on the transition period and the timeline for compliance with MDR 2017/745. Our experts can assist you in meeting deadlines and addressing all issues relevant to maintaining access for your medical devices to European markets.

Transition period and the timeline for compliance with MDR 2017/745 | TÜV Rheinland

The ideal partner for handling the replacement of the medical device directive

As a test house and specialist for market access throughout the world, we offer the medical device industry comprehensive services all under one roof. In addition to enabling you to navigate the transition to compliance with the new European Medical Device Regulation, our services include QM system auditing for medical device manufacturers, suppliers and sales offices as well as medical device testing. We are innovative and prepared for future topics in the area of digitalization, such as wireless connections, telemedicine, medical apps, cyber security, personal data protection, and more.

Ask our experts to get an early start on MDR compliance. Make an appointment today.

FAQ on the new MDR 2017/745

Our FAQ will answer the following questions:

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How long is the transition period for the MDR?

Three years, beginning on May 25, 2017. The regulations will be applied beginning on May 26, 2020.

How are certain high-risk products treated under the new MDR?

Under MDR, class III implants and active class IIb products which are intended to administer and/or remove medicinal products from the body are subject to a double safety mechanism. First, these products must undergo clinical consultation before they are placed on the market. Once on the market, they might be put through a scrutiny process.

What is the Unique Device Identification (UDI) system?

The Unique Device Identification (UDI) System is intended to allow the identification and facilitate the traceability of medical devices within the distribution chain. Manufacturers must assign a single product identifier to each product; this UDI shall appear in the technical documentation, the EU declaration of conformity and on the label or the packaging of the device. The information must be shared with the UDI database and is used to report problems in the field and also should help to reduce medical errors and to fight against falsified devices.

What is EUDAMED?

The acronym stands for European Database on Medical Devices. It is designed to collect information that can be shared among member states, the EU commission, notified bodies, economic operators and sponsors on marketed medical devices, conformity assessment procedures, Notified Bodies, certificates, registered economic operators, vigilance/adverse events, market surveillance and clinical investigations.

Are there new requirements for the technical documentation under the MDR?

Requirements are much more detailed regarding both content and regular updates of technical documentations and there is an increased focus on clinical assessments. Importantly, there will be no differentiation between class III documentation (MDD: design examination file) and the other classes.

Which non-medical devices are now covered under MDR?

Products intended for “aesthetic” purposes rather than medical purposes, such as colored contact lenses or devices used for liposuction, will be covered by the new regulation. A list of these products can be found in appendix XV of the MDR.

Does the MDR address the reuse of medical devices?

Member states can permit or ban reprocessing of singleuse products at national level. According to the new MDR a “reprocessor“ should be considered the legal manufacturer of the reprocessed device and therefore needs to meet the requirements of the regulation and, if applicable, also national requirements. This is one of the topics the European Commission still has to establish common standards for.

Manufacturers of class I reusable surgical devices are now required to contract a Notified Body to examine the aspects of their products related to reuse.

What changes do we see in the MDR in regard to medical software?

According to the new rule 11 (chapter VIII) software intended to provide data used for diagnostic purposes or to make therapeutic decisions now belongs to class IIa. In certain cases the software may even be classified into IIb or III.

When will the first MDR certificates be issued?

Notified Bodies can apply for the designation under MDR from November 26, 2017 on. The date for the JAT audit not only depends on the Notified Body´s quality of application, but also strongly on the resources of the national authorities and the EU commission. Taking the projected timelines for designation of notified bodies in the MDR into account, we project that certificates will begin to be issued no sooner than beginning or middle of 2019.

When will TÜV Rheinland issue the first MDR certificates?

We can confirm, that we prepare our application thoroughly, complete and of high quality. The date for the JAT audit for designation of a Notified Body for MDR is determined by the EU commission and strongly depending on the resources of the national authorities and the EU commission.

Is a pre-audit (mock audit) to verify compliance with the MDR requirements possible?

A Notified Body is only allowed to perform a pre-audit, if the respective manufacturer has lodged an application to this Notified Body. Thus, the prerequisite for a pre-audit would be the successful designation of a Notified Body for the MDR and the application of the respective manufacturer.

How can the requirement for the “Person responsible for regulatory compliance” be implemented?

In our understanding there are different options possible: there might be several people doing supporting work, but there is only one person who possesses the required qualification and thus is ultimately responsible. If tasks are assigned to several persons, this need to be defined and all of these persons need to fulfill the qualification requirements for the “Person responsible for regulatory compliance”.

More information

pdf FAQ – Frequently asked questions on MDR 283 KB Download
pdf Infographic – Important facts on the MDR revision 989 KB Download

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Learn more about MDR compliance!

Learn more about MDR compliance!

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