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Questions and Answers about the International Regulations for Medical Devices

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In which countries does TÜV Rheinland support market access?

As a testing and certification organization and specialist for worldwide market access, TÜV Rheinland offers the medical device industry a one-stop solution for a comprehensive range of services. We support you with obtaining market approval for medical devices in Asia (Japan, Taiwan, China), Australia, Europe, Canada, Russia, South America (Brazil), Ukraine and the USA.

What is the Medical Device Single Audit Program?

The Medical Device Single Audit Program (MDSAP) gives you the option to meet the quality management requirements for the approval of your medical devices in the participating countries of Australia, Brazil, Japan, Canada and the USA with only one single audit.

The MDSAP certificate is endorsed by the following international regulatory authorities:

• Australian Therapeutic Goods Administration (TGA)

• The Brazilian National Health Surveillance Agency (ANVISA)

• Health Canada (HC)

• Japanese Ministry of Health, Labor and Welfare (MHLW) & Pharmaceuticals and Medical Devices Agency (PMDA)

• United States Food and Drug Administration (FDA)

What regulations apply in Europe?

In 2017, the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) came into effect. The MDR replaces the MDD and the AIMDD with a transition period of now 4 years, while the IVDR replaces the IVDD with a transition period of 5 years. The new regulations form the central legal framework for marketing medical devices in the European Union.

Due to the COVID-19 pandemic, the passing of EU Regulation 2020/561 postponed the date of application of the MDR to May 25, 2021. The European Regulation on In Vitro Diagnostic Medical Devices 2017/746 (IVDR) came into force on May 25, 2017 and will be binding starting May 26, 2022.

TÜV Rheinland is one of a limited number of Notified Bodies for the MDR in Europe. Additionally, (as of November 19, 2020) we are one of five Notified Bodies for the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) 2017/746, and one of only four Notified Bodies worldwide covering both regulations. TÜV Rheinland is proud to a Notified Body holding both designations, and to be able to offer its customers comprehensive expertise on all required services as a single source provider.

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.

What is the Medical Devices Regulation 2017/745 (MDR)?

The MDR replaces the currently applicable directives for medical devices. It replaces the Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.

Due to the COVID-19 pandemic, the European Union adopted EU Regulation 2020/561, which postpones the date of application of the Medical Devices Regulation 2017/745 (MDR) from May 26, 2020 to May 26, 2021. Until then, manufacturers can still place new products lawfully on the market under the previous directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD). All existing MDD and AIMDD certificates will expire no later than May 26, 2024.

All manufacturers are advised to implement plans to transition to the requirements of the MDR.

Manufacturers must test their products for conformity with the MDR. A conformity assessment procedure according to MDR always equates to a re-certification and is mandatory for placing medical devices on the European market, beginning from the date of application of the MDR.

When will the MDR be mandatory?

The MDR came into force May 25, 2017 with a three-year transition period. Due to the COVID-19 pandemic, the transition period was extended by one year. This means, that starting May 26, 2021 all medical devices must meet the requirements of the Medical Devices Regulation (MDR) in order to be placed on the market in the European Union.

When do MDD and AIMDD certificates become invalid?

Medical devices that are still covered by a valid MDD and AIMDD certificate on May 26, 2021 may continue to be sold until the certificate expires, but no later than May 26, 2024.

This transition period only applies if:

• the medical devices continue to meet the requirements of the medical device directives and if surveillance by the current Notified Body is still ensured,

• additional requirements of the MDR are met as well, including requirements for the registration of market players and products, for post-market surveillance of the products and for reportable incidents, and

• no significant changes have been made to the design or to the intended use of the products.

Is TÜV Rheinland a Notified Body for the MDR? (Status: December 3, 2020)

Yes, TÜV Rheinland LGA Products GmbH is one of the Notified Bodies designated to perform conformity assessments under the EU Medical Devices Regulation (MDR) 2017/745 in Europe. At the same time, TÜV Rheinland is one of five Notified Bodies for the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) 2017/746 and one of four Notified Bodies worldwide that cover both regulations. We provide market access services for medical devices worldwide allowing TÜV Rheinland customers to receive all services from a single source provider.

Which products are covered by the MDR?

The MDR covers medical devices that previously fell in the scope of the Medical Device Directive (MDD, 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC).

The previous categorization of risk classes remains the same in the MDR. Most products will keep their classification. However, some otherwise unchanged products are now classified differently due to their material properties, as is the case for nanomaterials.

Reusable surgical instruments will be reclassified as Class I (Annex VIII of the MDR). Under the MDR, the conformity assessment by the manufacturer must involve a Notified Body that examines the aspects related to the reuse of the surgical instruments.

Also, certain products without an intended medical use are now regulated under the MDR. This affects products with a function and risk profile that corresponds to products with a medical purpose. Examples include colored contact lenses or medical devices for liposuction. The list of these products can be found in Annex XVI of the MDR.

What is the central database EUDAMED?

The central database EUDAMED was created to consolidate various information and databases, for example the registration of market players; information about conformity assessment procedures, certificates and Notified Bodies; the registration of devices with a Unique Device Identification (UDI) number; or details about incidents and clinical studies. The purpose of the database is to increase transparency.

Market players have been able to register for EUDAMED since December 1, 2020

When will the IVDR come into effect?

The EU Regulation on In Vitro Diagnostic Medical Devices 2017/746 came into force on May 25, 2017 and will be binding starting May 26, 2022. From then onward, the IVDR is mandatory for the initial market access of in vitro diagnostic medical devices in Europe.

What are the new requirements under the IVDR?

The IVDR 2017/746 places stricter requirements on

• documentation,

• clinical evidence,

• the Notified Body (NB) and surveillance by the NB.

Furthermore, the IVDR requires

• a Unique Device Identification Number (UID) for each medical device,

• an entry in EUDAMED,

• the appointment of a person responsible for regulatory compliance.

A successful transition to compliance with the IVDR requirements therefore requires manufacturers to deliver reliable documentation, high performance, safety standards, and effective risk management, as well as comprehensively and continuously assess their products before, during, and after the market launch.

We support manufacturers with the transition to the IVDR by providing services such as auditing of QM systems, testing in vitro diagnostic medical devices, and reviewing technical documentation. We keep you informed about certification-related issues with connection to transition periods, and together, we plan a suitable plan for you to access the European market with your in vitro diagnostic medical devices.

Do I have to re-test my products that are certified based on the old directive?

Starting May 26, 2022, manufacturers who place in vitro diagnostic medical devices on the EU market must comply with the requirements of the IVDR.

In some cases, in vitro diagnostic medical devices that were certified by a Notified Body (NB) under the IVDD may be sold until May 26, 2024, as long as certain conditions are met. These conditions include, that no major changes were made to the product, that the IVDD certificate is still valid and that the product remains under regular surveillance by the NB. All IVDD certificates will expire on May 27, 2024 at the latest.

What has changed in the classification of in vitro diagnostic medical devices?

The classification has fundamentally changed. The previous list-based classification for in vitro diagnostic medical devices is being converted into a rule-based system. It divides products into four risk classes, ranging from Class A (lowest risk) to Class D (highest risk). The involvement of a Notified Body is required for the CE marking of Class A sterile devices, and for all devices in Class B or higher.

Class Risk Examples

A Low risk for the individual and low public health risk Clinical chemistry analyses, sample containers

B Moderate risk for the individual and/or low public health risk Vitamin B12, over-the-counter pregnancy tests, urine test strips

C High risk for the individual and/or moderate public health risk Home blood glucose tests, HLA typing, cancer diagnostics, CDx, PSA tests

D High risk for the individual and high public health risk HIV/HCV screening of blood reserves, blood group tests (A, B, O)

Why is IEC 60601-1 called a series of standards? Which standards are included?

The IEC 60601 series of standards consists of several parts. Each part represents supplements and special specifications for active medical devices:

  • Base Standard: IEC 60601-1 contains the general specifications for safety, including essential performance characteristics.
  • Collateral Standards: IEC 60601-1-xx collateral standards contain general requirements for specific groups of medical electrical equipment that go beyond the requirements of the base standard. (e.g. IEC 60601-1-2 for EMC).
  • Particular Standards: IEC 60601-2-xx standards contain detailed requirements and testing for specific medical device products or features (e.g. IEC 60601-2-4 defibrillators)

What are the requirements of IEC 60601-1?

IEC 60601-1 imposes a variety of requirements on the product:

  • Classification of medical electrical equipment and systems - marking, labels.
  • Protection against electrical hazards from medical electrical equipment
  • Protection against mechanical hazards from medical electrical equipment and systems
  • Protection against hazards from unwanted and excessive radiation
  • Protection against excessive temperatures and other hazards
  • Accuracy of controls and indicators and protection against hazardous output values
  • Usability
  • Hazardous situations and error operation
  • Essential performance characteristics
  • Electromagnetic compatibility (EMC)

But the contents of the associated documentation are also regulated in the series of standards:

  • Instructions for use, service instructions
  • Risk management file with risk analysis according to ISO 14971:2019
  • Essential performance characteristics
  • Description of safety concept as well as first fault safety
  • Software documentation according to chapter 14 of IEC 60601-1 and IEC 62304
  • Suitability for use file according to IEC 60601-1-6 and IEC 62366
  • Proof of compliance with IEC 60601-1-2 incl. additional requirements
  • List of safety-critical components with data sheets and the corresponding test certificates (CB report, UL file, VDE, ID, etc.)

What is changing with the latest edition of IEC 60601-1:2005+A1:2012+A2:2020?

The new edition of IEC 60601-1 includes a large number of changes and references to other standards adapted to the base standard, such as the new edition of the risk management standard ISO14971:2019. The requirements for its documentation, especially for the software and usability have also been included and adapted to the current standards.

A brief overview of the most important changes:

  • Updating of normative references to current editions.
  • Reformulation of various term definitions, supplementary definitions from e.g. IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-8, IEC 60601-1-11, IEC 62366 inserted
  • Alignment to ISO 14971:2019 (risk management)
  • Requirements for operator protection (IEC 62368-1:2018)
  • Medical device labeling (safety signs, IP classification)
  • Signal lamps and alarms

Can TÜV Rheinland test and certify my medical device for my target market?

We are a globally operating Notified Body with a wide range of accreditations, testing facilities and qualified staff serving an extensive portfolio of customers across every industry. Our Technical Competence Center consists of experts on the latest standards and certification practices for IEC 60601 and IEC/ ISO 80601 series.

In addition, the CB Scheme procedure allows you to obtain multiple national safety certificates for your products and access to more than 50 markets. Getting the cTUVus Mark on your device extends your business markets across the USA and Canada. We conduct product testing and approvals as a member of the Nationally Recognized Testing Laboratory Program (NRTL) with OSHA (USA) and SCC (Canada).

We support you in the transition to the new MDR and IVDR.

Do you have questions about the testing and certification of medical devices?

Do you have questions about the testing and certification of medical devices?

Transition to the new regulation for medical devices and in-vitro diagnostic medical devices.