Medical device CE marking

2019-10

The MDCG (EU Medical Device Coordination Group) has released guidance concerning qualification and classification of software (Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)): MDCG 2019-11.

This guidance, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the regulations and guides on the application of classification criteria for software. The guidance also provides information related to placing on the market. The classification criteria (classification rules) are set out in Annex VIII of the MDR and IVDR. The guidance is not legally binding.

The criteria specified in the guidance shall also apply to applications (commonly referred to as Apps), whether operating on a mobile phone, in the cloud or on other platforms.

Additionally, an ongoing guidance development document has been released. This document indicates which guidances are under construction and when they can be expected to be released.

Source: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

2019-08

The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed)

The main purpose of this document (MDCG 2019-9) is to provide guidance on the presentation, content and validation of the SSCP.

The guidance can be downloaded in our library

Source: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

2019-05

The Medical Devices Regulation 2017/745/EU (‘MDR’) and the in-vitro diagnostic Medical Devices Regulation 2017/746/EU (‘IVDR’) have new requirements regarding the labeling of medical devices. To comply with this requirement within the short term and in a harmonised manner, before the international standard is available, MedTech Europe has published a guidance on symbols in May 2019.

The guidance can be downloaded in our library.

Source: https://www.medtecheurope.org/

2019-05

The European Commission has updated its manual on borderline and classification.

It includes now:

7. ACCESSORY TO A MEDICAL DEVICE OR AN IN-VITRO DIAGNOSTIC MEDICAL DEVICE
7.6. Automated external defibrillator storage units

8. CLASSIFICATION
8.32 Lubricants intended for alleviation of vaginal dryness

9. SOFTWARE AND MOBILE APPLICATIONS
9.12. Medication decision support software

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

2019-01

The UK has taken the critical step of asking Parliament to approve legislation to future-proof the regulation of medical devices in event of a no-deal Brexit. The proposed new legislation also introduces the new EU requirements contained in the Medical Device and IVD Regulations into national law.

It reflects the UK’s stated intention to continue to follow EU medical device rules for the time being until an announcement is made otherwise in the event of a no-deal Brexit, or in the framework of a Brexit with an agreed withdrawal period.
For medical devices, the key arrangements include: for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognized by UK law and allowed to be placed on the UK market; and the expansion of the MHRA’s registration system to all classes of medical device.

The proposed amendment can be downloaded here: http://www.legislation.gov.uk/ukdsi/2019/9780111179260/contents

2019-01

BSI heard on the 21 January from the MRHA that they are now designated to the MDR (EU 2017/745).

BSI has been designated for the full scope they have applied for.

Sources:
– BSI
– NANDO

 

2019-01

2018-10

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.25. Mattress covers against mites
1.22. Lubricants intended for body massages and/or sexual intercourse

8. CLASSIFICATION
8.31. Trial hip prosthesis heads or stems

9. SOFTWARE AND MOBILE APPLICATIONS
9.9. Product intended to facilitate conception based on basal body temperature
9.10. Product intended to facilitate conception and enable contraception based on basal body temperature
9.11. Stand-alone software application for conception and contraception purposes using data entered by the patient

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

2018-10

The European Commission has issued 5 new MDCG endorsed documents:

• MDCG 2018-3   Guidance on UDI for systems and procedure packs
• MDCG 2018-4   Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
• MDCG 2018-5   UDI Assignment to Medical Device Software
• MDCG 2018-6   Clarifications of UDI related responsibilities in relation to Article 16
• MDCG 2018-7   Provisional considerations regarding language issues associated with the UDI database

The guidances can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

2018-10

The MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom) would like to share the following:

By May 2020, some products that do not have an intended medical purpose will be required to comply with the new regulations for medical devices. These groups of products are listed under Annex XVI of the Medical Device Regulations (MDR). Further information about the specific requirements of the MDR on these groups can be found in this leaflet.

The leaflet can be downloaded here: library

Source: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr