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.

Starting May 26, 2021, manufacturers and new products must meet the new MDR requirements in order to be marketed in the European Union.

Medical devices that are still covered by a Directive certification may continue to be marketed until the end of the validity of the certificate, but no later than May 26, 2024. However, this transitional period only applies if the requirements continue to be monitored by the previous Notified Body, if the modified requirements are being met, such as the surveillance of the products placed on the market or the reporting of adverse events; and if no significant changes are made to the design or the intended purpose of these products.

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 successfully transition from the Directives to the requirements of the new Regulation, manufacturers must be aware of the necessary adjustments to be made to their quality management system and have prepared a detailed implementation plan. The necessary audits should be appropriately scheduled. Planning certification towards the end of the transition period carries high risk, because, after May 2024, manufacturers will be prohibited from placing products without valid MDR certification on the market. An effective strategy should be discussed with the future Notified Body and realistic plans should be in place to allow for the time required to transition and to evaluate the technical documentation according to the MDR requirements.

The cost expenditure of the Notified Bodies for the MDR notification has increased significantly compared to notifications under the Directives. Efforts to maintain the new MDR notification have increased as have the specified tasks requiring Notified Bodies to monitor certified manufacturers throughout the validity period of the MDR certificate(s), resulting in higher costs.

Manufacturers internal expenses are also increasing, not least because many manufacturers cannot directly switch completely from the MDD to the MDR, and must therefore have both systems certified in parallel for a certain period of time.

Costs for the new conformity assessments will therefore significantly rise in comparison over the period of five years.

For a certification procedure, the costs are calculated individually on an hourly basis, taking into account the size of the company, the number of locations, and the complexity of the products.

Our hourly rates* for the activities of TÜV Rheinland LGA Products GmbH (Germany) are as follows:

• Audit activities according to the MDR
  250 Euro
• Conducting unannounced audits under the MDR
  250 Euro
• Processing notifications of change or significant changes
  250 Euro
• Review of technical documentation according to the MDR
  350 Euro
• Involvement of a clinical expert in the review of the technical documentation
  350 Euro

*Hourly rates may vary by region

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.