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EU Medical Device Regulation MDR 2017/745

EU Medical Device Regulation MDR 2017/745

News: MDR transition period extended

On February 16, 2023, the European Parliament approved a proposal that will significantly ease the challenges of medical device manufacturers. With the latest extension of the Medical Devices Regulation EU 2017/745, they have the possibility to apply for an extension of the transition period for their products.

The new regulation is expected to enter into force shortly through publication in the European Journal. Manufacturers will then have the prospect of the following transition periods:

Please consider that manufacturers must demonstrate that they have already taken steps to convert to the new regulations in order to claim the extension. We offer support for all manufacturers who are looking for a professional and reliable Notified Body to address the challenges by MDR and IVDR. Contact us!

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.

The measure gives medical device manufacturers the opportunity to fully focus all possible resources on the fight against the COVID-19 pandemic. Medical device manufacturers play an important role, but challenging role. It is critically important that medical devices remain compliant and continue to be available in the EU in order to avoid shortages or delays of certain medical devices during these unique circumstances.

Beyond this situation, TÜV Rheinland would like to encourage its clients to keep in contact with us in order to continue planning activities to implement the Medical Device 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 advise, 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.

Your confident partner for handling the replacement of the medical device directive

As a testing and certification organization 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.

Consult with an expert to get an early start on MDR compliance.

Questions and Answers on the new European Medical Devices Regulation (MDR 2017/745)

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Has TUV Rheinland implemented/ amended the timelines of the services related to the medical device directive (MDD)?

Yes, along with this postponement other dates of applications of other provisions were adopted as well and TUV Rheinland has amended the deadline for submission. Please contact your TUV Rheinland representative for more information.

What is the European Medical Device Regulation (MDR)?

In order to meet the constantly evolving requirements for medical devices, institutions of the European Union such as the Commission, the Parliament and the Council held lengthy negotiations and have agreed to a compromise on a complete overhaul of the legal regulations for medical devices.

The new text was published as regulation – and as such as directly applicable law – on May 5, 2017. The new MDR (Medical Device Regulation) 2017/745 is set to replace the existing national requirements of the Medical Device Directive (MDD 93/42/EEC) within a specified time frame.

Further information on the revision of the Medical Device Regulation can also be found on the EU website.

What is the central database – EUDAMED and UDI?

A key element of the MDR is the introduction of a European database in order to increase transparency, ensure traceability of medical devices, and to facilitate the flow of information between manufacturers and users of medical devices, Notified Bodies, EU member states and the European Commission. Eudamed will integrate various information or databases, e.g. for the registration of products with a unique UDI (Unique Device Identification) number as well as for market players, conformity assessment procedures, certificates, Notified Bodies or even incidents and clinical trials.

What will change for the Notified Bodies?

Now, the notification procedures and the procedures for monitoring Notified Bodies are regulated in more detail, they are stricter and meant to result in the further harmonization of the requirements. This (enables Notified Bodies to comply with current requirements and thus) ensure(s) an even higher level of quality and safety for medical devices. Furthermore, the Notified Bodies are required, among other things, to employ more physicians or clinical experts and to ensure a rotation of lead auditors for surveillance audits.

What are unannounced audits?

Notified Bodies are under obligation to conduct an unannounced audit at least once every five years. These audits increase the probability that manufacturers are manufacturing their products in full compliance with the applicable regulations. The inspection of products is an important element of these audits.

What are the new challenges for manufacturers, suppliers, importers, distributors and authorized representative in Europe?

For a long time, there have been extensive requirements that manufacturers in the EU had to meet. These requirements are now specified in more detail and extend across the entire medical device supply chain. Systems for risk management, vigilance and post-market surveillance must be implemented and interlinked as integral parts of the overall quality management. The resulting information must be systematically analyzed by the manufacturer and documented in periodic reports to continuously update the technical documentation and support a reliable risk assessment. Individuals entrusted with conducting clinical evaluations must demonstrate a high level of technical expertise. In addition, manufacturers must employ a specific person who is responsible for monitoring compliance with regulatory requirements. Furthermore, manufacturers are required to maintain liability insurance for the financial coverage of any damage that may be caused by defective products.

What is the dual safety mechanism for high-risk products?

The basic principle for carrying out conformity assessment procedures remains the same. However, under the MDR, the following products are now subject to a dual safety mechanism:

  • Implantable Class III products
  • Active Class IIb products intended to administer and/or remove medicinal products, body liquids or other substances to or from the body to which common specifications do not apply or if this is the first certification for such a product.

The dual safety mechanism consists of:

  1. Pre-market clinical consultation procedure
  2. Post-market control of the conformity assessments (scrutiny procedure)

What products with a solely aesthetic or non-medical intended use as specified by the manufacturer are now covered by the MDR?

Such products in general fall outside the scope of the Medical Device Regulation. However, aesthetic products or products for non-medical use that are similar in function and risk profile to products intended for medical use are covered by the new regulation. A list of these products can be found in Annex XVI of the MDR. These products include e.g. colored contact lenses or medical devices for liposuction.

What are the new regulations for the reuse of medical devices?

Member states may either permit or prohibit the reuse or recycling of single-use products at the national level. Under the new MDR, such a “recycler” is considered a manufacturer and must therefore comply with both the regulation requirements and applicable national mandates. The EU Commission has yet to define common specifications on this topic.

In the future, manufacturers of Class I reusable surgical instruments will also need to involve a Notified Body. This Notified Body however will only review the aspects related to the reuse of the products.

What is the new classification rule in the MDR that applies only to software?

Under the new Rule 10a, software designed to provide data used to make decisions for diagnostic or therapeutic purposes is now classified as Class IIa. This also applies to software that previously fell under Class I.

However, if those decisions have implications that may directly or indirectly cause death or lead to an irreversible deterioration of health, the software is now classified as Class III.

This is new for software that is neither part of a Class III medical device nor controls or influences such a device.

When do medical device manufacturers need to comply with the requirements of the new MDR?

MDD and AIMDD certifications issued prior to May 26, 2021 will continue to be valid latest until May 26, 2024. However, with the extensions rules approved by the European Parliament on February 16, 2023 which turned into force by publication within the European Journal on March 20, 2023, manufacturers have the opportunity to apply for a further extension for their products. The new deadlines depend on the classification of the medical device. Manufacturers must also demonstrate that they have already taken steps to convert to the new regulations in order to claim the extension, such as assuring continued surveillance of the products by a Notified Body, the reporting of adverse events and that no significant changes are made to the design or the intended purpose of the products that are to take profit of the extension.

What happens if my certificate is not issued before the end of the transition period?

There is a transition period for manufacturers to apply for the new MDR certification for devices currently certified under the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD).

Certificates issued during the transition period under the MDD and AIMDD remain valid for the entire period, unless they exceed four years after the date of application. The validity of MDD and AIMDD certificates after the date of application depends on the compliance with provisions specified in Article 120 (3).

If you do not receive a certification during the transition period and your MDD certificate expires during that time, you must withdraw your products from the EU market until they are certified under the new MDR.

Which products are covered by the MDR?

The Medical Device Regulation covers all medical devices that previously fell in the scope of the Medical Device Directive (MDD, 93/42/EEC) and all products regulated under the previous Active Implantable Medical Device Directive (AIMDD, 90/385/EEC).

Will there be any changes to the classification of my medical device?

The previous system with four classes remains in place. Classification for most products will not change, but there is some revision where the material properties of otherwise unmodified products may lead to classification changes – for example nanomaterials. A number of software products may also be subjected to changes in classification (see question 9).

Furthermore, in a new class of Class I medical devices, manufacturers of reusable surgical instruments are now required to involve a Notified Body for MDR to assist with conformity assessment.

Classification rules can be found in Annex VIII of the new regulation.

Another new provision allows for MDR regulation of some products without medical purpose. The preliminary list of those products can be found in Annex XVI.

May I make any changes after May 26, 2021 to the intended use of products that I would like to continue to market as MDD-certified products?

The MDR specifies that no changes may be made to the intended use or the design of medical devices to be placed on the market as MDD-certified products during the transition period. Any planned changes that had to be previously registered under the MDD must still be reported to the Notified Body.

Products that are to undergo changes to their intended use or design must first pass a conformity assessment procedure under the MDR.

What will change for medical devices that include medicinal products?

The technical requirements for these products remain unchanged. As part of the conformity assessment the MDR stipulates that such Class III products continue to be subject to a consultation procedure with a medicinal products competent authority in order to assess the quality and safety of the drug component and to evaluate the benefit/risk balance of the ingredient in the product.

What will change for my medical devices that are made using materials of animal origin?

The technical requirements for these products remain unchanged. Under the MDR, these Class III products continue to be assessed taking into account the additional requirements of Regulation (EU) No 722/2012.

How can manufacturers prepare for the new MDR?

In order to benefit from the extension of the transition timelines for medical devices from MDD to MDR resulting from the amending regulation (EU) 2023/607, manufacturers must have the quality managemenystem updated to MDR requirements by May 2024.This requires awareness of the necessary adjustments to be made to the existing quality management system and the existance of a detailed implementation plan. The necessary audits should be appropriately scheduled. Planning certification towards the end of the transition period carries high risk, because delays beyond May 2024 will be prohibited manufacturers from placing products on the market. The new extended timelines only fall into place if the timelines defined by the European Parliament within (EU) 2023/607 are duly met. An effective strategy should be discussed with the Notified Body and realistic plans should be in place to allow for the time required to evaluate the respective documentation according to the MDR requirements.

When will TÜV Rheinland start providing MDR services?

We are recognized as the fifth Notified Body for the Medical Devices Regulation MDR 2017/745. Following the publication in the Commission’s NANDO database, we will be accepting applications for MDR conformity assessments.

Which languages are accepted for submission of documentation and for any related correspondence?

Documents required for conducting the assessment procedure (e.g. technical documentation) must be submitted in either German or English. An arrangement is needed prior to commencing the certification process, for customers to submit the documents in another official language of the European Union.

More information for download

pdf MDR Technical Documentation Guidance Document 511 KB Download
pdf Annex A Checklist for MDR Technical Documentation Submissions 1 MB Download
pdf Infosheet – Important facts on the MDR revision 310 KB Download
pdf Questions and Answers on the new European Medical Devices Regulation (MDR 2017/745) 490 KB Download

More information for download

MDR Declaration of Interest

EU Medical Devices Regulation (MDR)

Amendment of the Regulation (EU) 2017/745

MDR Informationen in Deutsch

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