#EUDAMED

[cert3global]

Understanding the Role of the UK Responsible Person: Your Key to Compliance

One of the most significant consequences of Brexit for businesses placing products on the UK market is the emergence of the UK Responsible Person (UKRP). Similar to the European Authorized Representative (EAR) under the EU legislation, a UKRP acts as the point of contact for regulatory authorities and consumers. They ensure compliance with UK laws and regulations, taking on responsibilities formerly carried out by the EAR.

[idagnyheter]

VGR litar på Oracle trots bristerna i Millenniums CE-märkning

Samma dag som det gigantiska journalsystemet togs i bruk, med start i Borås, påbörjade Läkemedelsverket en revision av Millennium. Även om EU-förordningar kräver en säkerhetsklassificering som kallas “2a” för sådana patientkänsliga system i den gemensamma Eudamed-databasen, klassificeras Millenniums delar endast där på den lägre nivån, “1”. Tillverkaren Oracle har inte heller registrerat sig hos…

[omcmedicalblog]

MDCG Position Paper on the Implementation of UDI Requirements - OMC Medical Limited

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.  

The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only body that can provide legally binding interpretations of Union law is the Court of Justice of the European Union. 

The Unique Device Identification (UDI) system, which is introduced in Article 27 of Regulation (EU) 2017/745 on Medical Devices (MDR), intends to improve device identification and increase the efficacy of post-market safety-related actions for devices, among other things.

Particular UDI assignment solutions are envisioned to maintain proportionate data-entries in EUDAMED for some highly customized items. Therefore, until solutions are finalized, this position paper aims to clarify the implementation of UDI regulations starting on May 26, 2021, for contact lenses, spectacle frames, spectacle lenses, and ready readers.

The relevant sections of Regulations (EU) 2017/745 (particularly Chapter III and Annex VI) and associated UDI guidance materials should be studied with this position paper. 

Manufacturers must abide by the requirements pertaining to the UDI system mentioned in Article 27 as well as the registration requirements mentioned in Articles 29 and 31 of the MDR, according to Article 10(7) of the MDR.  

According to Article 27(3) MDR, the maker must assign a UDI to any item (except from custom-made devices) before putting it on the market. This also applies to all higher layers of packaging. Furthermore, as stipulated in Part C of Annex VI, Article 29(3) requires the makers to assign a Basic UDI-DI to the device. 

UDI carriers must be listed on the device’s label and on all upper layers of packaging, according to Article 27(4) MDR. In compliance with Article 123(f) MDR, this requirement is applicable to implantable devices as well as class III, class IIa, and class IIb devices starting on May 26, 2021, class I devices starting on May 26, 2025, and class IIa and class IIb devices on May 26, 2023.  

Lastly, Basic UDI-DI and the other essential data items for that device mentioned in Part B of Annex VI must be provided, according to Article 29(1) MDR. However, as stated in Article 123(3)(e) MDR, Article 29(4) MDR regarding device registration becomes effective 24 months following the date of publication of the notice mentioned in Article 34(3) MDR. 

In light of the aforementioned, and taking into account that:  

(a) the MDCG UDI WG is developing a specific UDI assignment solution for contact lenses, which may also be extended to spectacle frames; and  

(b) while a specific UDI assignment solution is agreed upon for spectacle lenses and ready readers, its practical application has not yet been formalized, the following clarifications should be observed in terms of UDI assignment, carrier labeling, and registration. 

1. UDI Assignment: As of May 26, 2021, and until particular UDI assignment solutions are finalized, the aforementioned products are anticipated to comply with the UDI assignment duties outlined in Art. 27(3) and Art. 29 (1) MDR. 

2. UDI Carrier Labelling: As of May 2021, May 2023, and May 2025, respectively, implantable devices, Class III devices, Class IIa/IIb devices, and Class I devices must comply with UDI labeling regulations. Given that most of the above specified goods are Class I and Class IIa/IIb devices, it is anticipated that there will be enough time for the label to accurately reflect the UDI assignment solutions. 

3. UDI & Device Registration: 24 months following the date on which the notification

Originally Published at: https://omcmedical.com/mdcg-position-paper-on-the-implementation-of-udi-requirements-for-contact-lenses-spectacle-frames-spectacle-lenses-ready-readers/

[omcmedicalblogs]

LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE

Legacy medical devices include all previously regulated devices under the Medical Devices Directives (MDD 93/42/EEC 90/385/EEC) and In-vitro Diagnostic Devices Directive (IVDD 98/79/EC).

Medical Device Coordination Group (MDCG) published the guidance documents on the Application of EU MDR to legacy devices and Legacy device management for Legacy devices.

There are three terminologies to guide the manufacturers – old devices, legacy devices and MDR devices.

‘Old devices’ were placed on the market before 26 May 2021, holding valid Medical Device Directive Certificates or the AIMDD certificates.

‘Legacy Devices’ are those devices that have a valid CE certificate under the directives MDD and IVDD that were placed after 26 May 2021 or those that require a conformity assessment to be carried out.

A Class III device, for example, can be considered a legacy device because of the conformity tests done and valid CE certificates. Class Is / Im devices with self-declared certificates do not fall under this category.

Legacy devices must be MDR compliant under the prescribed transitional timelines set by the MDR (2017/745). The transitional provisions and timelines can be found in Article 120 of the EU MDR.

https://jpcdn.it/img/f11f7ed767582b76241c3f66062badfa.png

This topic focuses on the Legacy Devices requirements per MDR 2017/745. EU MDR aims to implement the following aspects of medical devices:

Identification- This is achieved by Unique Device Identifiers (UDI).

Transparency- The Database available in EUDAMED (European Databank on Medical Devices.) ensures that the device description and details of different economic operators are open and easily accessible for users.

Surveillance-Post-Market Surveillance, vigilance reporting and Periodic Safety Update Reports (PSUR) are prime importance under MDR.

Identification of Legacy Medical Devices

To ensure proper identification of medical devices, UDI is implemented under MDR. Read more about UDI in our article on UDI (Unique Device Identification) system. For legacy devices, the identification is made possible with the help of EUDAMED-DI.

Some manufacturers may have implemented UDI to their medical devices. In such cases, the device identifier is obtained from the UDI-DI. Devices that do not have UDI should have a EUDAMED-DI designated by the manufacturer.

The European Commission document on the Management of legacy devices can be used to understand the different device identifiers.

Application of Post Market Requirements to Legacy Devices

All relevant requirements mentioned in MDR apply to legacy devices as well. This includes post-market surveillance, market surveillance and vigilance.

Manufacturers need to keep in mind the information required under Article 83 and Chapter VII of EU MDR while implementing a post-market surveillance system.

The Notified bodies must consider the new requirements applicable to manufacturers resulting from the transitional provisions as part of the surveillance framework.

Application of other MDR requirements to legacy devices

Application of all other requirements should be implemented to contribute to post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. This ensures an all-rounded and well-functioning surveillance system.

The other MDR requirements applicable to legacy devices are as follows.

Article 10(12-15)

Obligations of manufacturers for market surveillance, field safety notices and vigilance.

Article 11 (3) (c-g) and 11 (7)

Obligations of Authorised representatives.

Article 13 (2,4,5,6,10)

Importer obligations for IFU, labelling, and register of complaints.

Article 14 (2,4,6)

Distributor obligations.

Article 22

Article on system and procedure packs.

Article 29

Article of registration of medical devices and UDI.

Article 31

Article of registration of manufacturers, authorized representatives, and importers.

Article 83-100

Articles 83-88 on PMS, PSUR, vigilance, serious incident reporting, field safety corrections, and trend reporting.

Articles 89-99 on analysis of data, implementing acts, market surveillance activities, electronic system on market surveillance and others.

Articles 98-100 on Preventive health protection measures, Good administrative practice, and electronic system for market surveillance.

Get detailed information here: https://omcmedical.com/legacy-medical-devices-requirements-in-europe/

[avajosheph]

Ensure your medical devices meet European standards with CE Marking. Stay compliant and gain market access across the EU. Maven is a regulatory consultancy providing one-stop solution for the CE marking of your medical devices, providing overall support with technical documentation, identification of external testing and coordination with associate laboratory partners, generating UDI’s, EUDAMED registration, appointment of EC REP (European Authorised Representative) and coordination with notified body.

[mariacarey544]

Deciphering Medical Device Registration in the EU: A Comprehensive Handbook 

Navigating the regulatory maze of medical devices within the European Union (EU) can be daunting, particularly concerning registration. This comprehensive guide aims to empower manufacturers with the requisite knowledge to effectively navigate the Medical Device Registration EU process, ensuring compliance with the Medical Devices Regulation (MDR) and instilling confidence in bringing their medical devices to the European market. 

The Evolving Regulatory Landscape  

The Medical Device Regulation (MDR) (Regulation (EU) 2017/745) fully replaced the previous Medical Devices Directive (MDD) in May 2021. The MDR introduces more stringent requirements than its predecessor, with the objective of enhancing the safety, quality, and transparency of medical devices available in the EU. 

Key Aspects of Medical Device Registration Classification:  

The initial step entails classifying your device based on its intended purpose and inherent risks. The MDR outlines four risk classes, ranging from Class I (Lowest Risk) to Class III (Highest Risk), each dictating specific conformity assessment routes required for CE marking, which is mandatory for placing medical devices on the EU market. 

Unique Device Identification (UDI): All medical devices in the EU must be equipped with a Unique Device Identification (UDI) system, facilitating efficient traceability, vigilance, and market surveillance. Manufacturers must assign UDIs to their devices and submit them to the European Database on Medical Devices (EUDAMED). 

EUDAMED Registration: EUDAMED serves as a centralized repository for information on all medical devices and stakeholders involved in the EU supply chain. Manufacturers are obligated to register themselves and their devices on EUDAMED, providing comprehensive details such as device information, technical documentation, and contact details of the Person Responsible for Regulatory Compliance (PRRC). 

Conformity Assessment Procedures: The conformity assessment procedure applicable to your device is contingent upon its risk class. Lower-risk devices (Class I and IIa) typically involve fewer complex procedures, while higher-risk devices (Class IIb and III) necessitate involvement from a Notified Body, independent organizations designated by the EU to assess compliance with MDR requirements. Conformity assessment procedures may involve internal production control system audits, technical documentation review, and clinical investigation and evaluation by a Notified Body. 

Additional Considerations  

To ensure safety and functionality, medical devices undergo conformance evaluation by the European Union (EU), with involvement from the European Medicines Agency (EMA). Additionally, medical devices are regulated at the EU Member States level. 

Technical Documentation: Manufacturers must compile comprehensive technical documentation demonstrating their device's adherence to MDR requirements, serving as the basis for conformity assessment by Notified Bodies. 

Person Responsible for Regulatory Compliance (PRRC): It is mandatory to appoint a PRRC within the EU, responsible for ensuring MDR compliance throughout the device's lifecycle, including post-market surveillance activities. 

Post-Market Surveillance: Manufacturers have ongoing obligations to monitor their devices after-market launch, including reporting serious adverse events and incidents to relevant authorities and implementing Corrective and Preventive Actions (CAPA) to address identified risks or non-conformities. 

Seeking Expert Guidance: Given the intricacies involved, it is highly recommended for manufacturers to seek guidance from qualified regulatory consultants or legal professionals specializing in EU CE Marking medical device regulations. They can provide invaluable assistance in navigating the registration process, ensuring compliance with MDR requirements, and facilitating successful market entry in the EU. 

Overview of the Medical Device Registration Process 

Stage 

Description 

Classification 

Categorize device based on risk (Class I-III) 

Unique Device Identification (UDI) 

Assign unique identifier for traceability 

EUDAMED Registration 

Register device and details in EUDAMED database 

Conformity Assessment 

Follow procedures based on class (internal audit, notified body review, etc.) 

Additional Considerations 

Technical documentation, Person Responsible for Regulatory Compliance (PRRC), Post-Market Surveillance (reporting incidents, CAPA) 

Table 1: Overview of the Medical Device Registration Process 

Conclusion 

Comprehending and adhering to the medical device registration EU process is imperative for manufacturers seeking to introduce their products to the European market. By complying with MDR requirements and leveraging expert guidance, when necessary, manufacturers can ensure patient safety, regulatory compliance, and a prosperous market presence within the EU. 

[allensmith01]

In the UK, CE for Medical Devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has introduced its own regulatory system for medical devices, which includes the UK Conformity Assessed (UKCA) mark. To place a medical device on the UK market, manufacturers must adhere to the UK regulations and requirements, including conformity assessments.

[jonesmiller001]

We deal with the aspects of professional CE Marking Consultancy for medical devices. We Are A Premium Regulatory Compliance Solutions Provider For Medical Devices/IVDs. CE Marking for Medical Device Service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes spanning a diverse range of indications.

[adamsbrown01]

Australia has implemented a new regulatory framework for CE mark for medical devices, moving away from the CE marking system used in Europe. The Therapeutic Goods Administration (TGA) in Australia is responsible for regulating medical devices. It's essential to note that regulations and requirements can change over time. I recommend checking the latest information on the TGA website or consulting with our regulatory expert to ensure compliance with current regulations regarding medical devices in Australia

[cert3global]

Mastering Post-Market Surveillance: Safeguarding Medical Devices

Post-market surveillance is a systematic approach that helps manufacturers monitor and assess the performance and safety of their medical devices once they are on the market. It involves the collection and analysis of data from various sources, such as user feedback, complaints, adverse events, and clinical studies, to ensure that any potential risks or issues are identified and addressed promptly.

[omcmedicalblog]

Swiss Manufacturer Obligations | OMC Medical Limited

1. Manufacturers outside Switzerland will need to appoint Swiss AR.

2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity assessment procedure for devices in due time prior to the expiration of their current certificate of conformity.

3. The Manufacturer reserves the right but needs to inform AR about any discontinuities of the devices upon expiration of their current certificate of conformity.

4. As per the latest application of the ordinance, for all devices made available on the Swiss market, the manufacturer should ensure: I. The device should be CE marked. II. The technical documentation and the declaration of conformity of the device has been drawn up. III. Requesting Swissmedic for the Swiss Single Registration Number (CHRN), which is used to identify the manufacturer, authorised representative, or importer and is will also need to register in the EUDAMED database issuing the Single Registration Number (SRN). IV. Labelling of the device in accordance with the ordinance accompanied by the required Instructions For Use (IFU). V. Assigning UDI to medical devices before placing them in the market and reporting to Swissmedic. VI. Establishment of a post-market monitoring system and defined necessary corrective measures. VII. Maintenance of the quality management system.

5. Manufacturers should report serious incidents associated with their medical devices to Swissmedic and should also initiate a Field Safety Corrective Action (FSCA) monitored by Swissmedic for the medical devices placed on the market in Switzerland. FSCA is used to reduce risk of death or severe deterioration in the health of the end-user associated with the medical device and may include the return of a medical device to the supplier, device – modification, exchange, or destruction.

6. The Manufacturer will not delegate to the AR the obligations laid down in Articles 16 – 17, 46 – 47, 50, 56, and 66 of the ordinance. The corresponding obligations in the (EU) 2017/745 are Article 10 (1) – (4), (6) – (7) and (9) – (12).

Originally Published at: https://omcmedical.com/swiss-manufacturer-obligations/

[izielhealthcare]

MDD to MDR Transition

Why is the modification in the regulation (MDD to MDR Transition) adapted?

History: You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer.

Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD.

How do we adapt to MDR?

·         Gap analysis while considering additional requirements of MDR.

·         Refer Annexure XVII of MDR

MDR focuses on the safety and performance assurance of the devices placed on the market. MDR assures that the product causes no harm to the customers. Clinical and Non-Clinical testing methods include Clinical Investigation, PMCF studies, Literature Searches Screening and Appraisal, bench tests, in-vitro tests, biocompatibility testing, and product-specific performance Tests (if any) are utilized to establish clinical evidence for demonstrating the safety and performance of the device. The Manufacturing facility audits are conducted as per ISO 13485 to comply with Cleanroom requirements and applicable standards. Corrective and Preventive Actions (CAPA) needed to be taken depending upon the severity of complaints generated through Field Safety Notices/Field Safety Corrective Actions. The IFUs and electronic IFUs are to be supplied by the manufacturer. Product retractability with UDI implementation has become a must for troubleshooting and the appropriate diagnosis of the complaint or defect related to the product.

Let us identify the requirements in MDD to MDR transition.

·         The major changes to be adapted in MDR.

·         MD Classification

·         Clinical Data Sources

·         Risk Management

·         Process Validation

·         Software Validation

·         GSPR checklist

·         Product Retraceability

 Major Inclusions in MDR

·         PRRC

·         SRN for Economic Operators

·         Annexure XVI includes products without an intended medical purpose like            contact lenses, brain stimulators, cosmetic products, etc.

·         Active Implantable Medical Devices

·         Sterilization

·         EN ISO 13485 and MDSAP Requirements

·         Conformity Assessment Routes

·         EUDAMED, UDI and Labelling

·         Technical Documentation

·         Clinical Evaluation

·         Clinical Investigation and PMCF

·         Reporting of serious incidents or failures to member states and trend reporting

·         IFU and eIFU Requirements

·         Cybersecurity

·         SSCP linked to EUDAMED open to all end-users (including a layman)

·         GSPR

 We at IZiel Healthcare have a long-standing collaboration with Obelis, a Belgium-based (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. This collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking of global medical devices through technical support, consultancy, representation, and device registration services.

[hpcosmos]

First MDR certified treadmills at h/p/cosmos - EU Declaration of Conformity for MDR treadmills

 

Yesterday, the first EU Declaration of Conformity according to the new Medical Device Regulation MDR (EU) 2017/745 for the risk class IIb medical devices got signed. Therefore, as of yesterday, the latest design treadmill series quasar and pulsar with MCU6 user terminal are now available as medical grade devices.

 

Under the overall guidance of Authorized Signatory and PPRC Nadine Schott, h/p/cosmos received the MDR certificate for medical devices in November 2022. Now, few months later and under the lead of R&D Project Manager Manuel Bernauer, the first EU Declaration of Conformity according to Medical Device Regulation MDR (EU) 2017/745 was signed for quasar med and pulsar med with MCU6.

 

Last year’s MDR quality management certification was paving the necessary “regulatory way” for this step.

Looking back on 35 years of experience in developing and manufacturing high profile diagnostics and rehabilitation treadmills, ergometers and speedlab devices, this step can be seen as a giant leap and milestone in the company history.

The new MDR certified treadmills are already listed in EUDAMED Database under Economic Operator Manufacturer SRN: DE-MF-000006147

 

Franz Harrer, Co-Founder and CEO as well as Dr. Björn Zimmermann, Authorized Signatory, took the chance to thank Manuel Bernauer, Nadine Schott and of course the complete involved R&D team and other team members after yesterday’s Gatekeeper Meeting for Gate 4 (market phase with EU DoC).

 

We would also like to thank all partners, suppliers and customers for their support in the development and path to market maturity.

A very special thanks is dedicated to our customers and partners involved in the pilot series and field test devices for this treadmill series. It was of tremendous help and massive effect to receive the feedback during the usability tests as well as during the validation process for the medical devices.

#design #development #project #medical #MDR #certification #productlaunch

[doriskitson]

UK REP

As a prominent provider of Total Quality Assurance services, we specialize in delivering comprehensive solutions for the medical devices industry globally. Our range of services covers inspections, trainings, CE marking, ISO certifications, 60601 testing, and testing of electrical and electromedical products, making us a one-stop-shop for all your quality assurance needs. We also offer customized solutions to assist you in achieving and maintaining regulatory and commercial success. Our services include European Authorized Representative and UK REP services, certificate for Free sales, Eudamed Registrations, and Clinical Literature Review to ensure your products comply with the latest regulations and standards. With our expertise and experience, we provide reliable and efficient solutions to help you meet your business goals while maintaining the highest quality standards. Trust us to be your partner in ensuring the safety and efficacy of your medical devices.

[alpinequalityconsultant]

Alpine Quality Consultants provide guidance & support for compliances by highly qualified, experienced and professional Advisors & Experts.