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Advena Ltd UK, Instrumental in Forming a New Trade Association: – UK Responsible Person Association (UKRPA).

Advena Limited UK, in our continuing endeavour as a leading UK based regulatory consultancy organisation are at the forefront of establishing a new trade association in the UK. Specifically aligned with the UK’s medical device regulations and with direct communication links to the Medicines and Healthcare products Regulatory Agency (MHRA).

This new trade association will assist Advena in obtaining key regulatory information in advance of publication and consequently Advena are significantly better placed to advise those clients who require the services of a UK Responsible Person (UKRP).

Non-UK based medical device manufacturers must now appoint a UKRP as part of the regulatory compliance process for UK market access. For further details regarding this service please contact Advena Ltd UK.

Email: ukrp@advenamedical.com

Quality Management Systems (QMS) Under the MDR

Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. Article 10 (9) of the MDR goes into further detail.

Manufacturers should be looking closely at their QMS to ensure it meets the requirements of the Regulation. A QMS to ISO 13485:2016 will cover most of these aspects, but not all. Therefore, it will be vitally important to carry out a review of your QMS.

The implementation of the MDR to 26th May 2021 is not far away, so please use this time wisely.

If you don’t have the resources internally or locally, remember Advena have a team of consultants who can help and should you need our assistance please do contact us and we will happily discuss and provide you with a quotation to review your QMS. If you need to implement a new QMS, we can also quote for this.

Email us at: Info@advenamedical.com

The Deadline for the MDR Transition is Fast Approaching – Are You Prepared?

Hopefully, the answer is yes. May 26th, 2021 is only a matter of months away and time is short.

Please remember Advena Ltd is well placed to help those clients who do not have the necessary resources, either internally or local to their operation. We have a team of consultants, based in our offices both in the UK and Malta with a wide range of experience across the whole platform of device classifications.

Whether you need a new technical file creating or an analysis of your existing documentation and what must be done to upgrade to the MDR, we have a service that can help.

If you just need certain sections of your documentation creating or reviewing, such as Risk Management or the critically important Clinical Evaluation Report section, we can also help, or perhaps with another sections of your technical files.

Remember, you will also need to update device labelling, packaging, IFU’s etc. and while EUDAMED is not fully operational, applicable devices must be registered the competent authority where your Authorised Representative is based, there is so much to do in these remaining few months, do not delay, get in touch if you need assistance.

For further details and a quotation, Email us at: info@advenamedical.com

MDR ARTICLE 120(3) TERMS AND CONDITIONS

It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions:

From 26 May 2020:

  • The device continues to comply with the Directive.
  • There are no significant* changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

  • Post-Market Surveillance [Article 83-86, 92, Annex III]
  • Market Surveillance [Article 93-100]
  • [Article 87-92]
  • Registration of economic operators and devices [Article 31 and 29]

* The MDCG have produced guidance on significant changes, please see this link.

Whether a change in design or intended purpose may be considered as significant shall be determined on a case by case basis, however, the following changes shall not be considered to be significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

The Notified Body who has issued the AIMDD/MDD certificate shall continue to be responsible for the surveillance relating to the devices it has certified.

Unique Device Identification (UDI) System EU2017/745 & EU2017/746

The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes. Note, this requirement applies to all devices apart from custom-made and investigational devices.

The above is the proposed symbol to be used for medical device labelling.

UDI Anatomy

The product specific UDI is comprised of two parts: the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI).

UDI-DI: This portion of the UDI is both specific to the manufacturer and device-group. This is considered to be the “access-key” to the UDI database information.

UDI-PI: This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series.

Both the UDI-DI and UDI-PI may be made available in a numeric or alphanumeric code. Together, they are known as the device’s UDI which shall be displayed on the “UDI carrier”. We will discuss this later on in this article.

 

Basic UDI-DI

The Basic UDI-DI represents a device-type described as device with the same intended use, risk classification and design and manufacturing characteristics. It will be the key to device-specific information on the Eudamed database.

The Basic UDI-DI will need to be made available on specific documentation (Declaration of Conformity, Summary of Safety and Clinical Performance, Certificates) however it shall not show on the packaging or label of the device.

The Basic UDI-DI will be made up of a number of elements which shall include reference to the issuing agency, the manufacturer, the device group, and a number of check digits.

Guidance on Basic UDI-DI and changes to UDI-DI

 

Issuing Entities

In its implementing decision on 6 June 2019, the European Commission (EC) designated 4 issuing entities to operate a UDI assignment system for medical devices: (1) GS1 AISBL; (2) Health Industry Business Communications Council (HIBCC); (3) ICCBBA; and (4) Informationsstelle für Arzneispezialitäten — IFA GmbH. Each of the issuing entities use a specific coding system in accordance with their own standards; however, these coding systems are translatable to the EU Regulations requirements on UDI. E.g. GS1 have developed the term Global Model Number (GMN) for the Basic UDI-DI, Global Trade Item Number (GTIN) for UDI-DI, and Application Identifier (AI) for UDI-PI.

Commission Implementing Decision (EU) 2019/939

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