EU Medical Device Regulation MDR 2017/745

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.

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.

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.

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.

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.

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.

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)

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.