Medical device CE marking

2020-10

By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels.

The use of symbols on the label is an effective way of compliance and it is permitted by the IVDR. By including these symbols proposed by MedTech Europe, the intended user of your device will be clear. It will also remove the necessity to translate that indication into all EU languages.

The document can be downloaded in our library

Source: MedTech Europe

2020-08

The European Commission has published the first common specifications under the MDR. It concerns reprocessing of single use devices.

Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation.

To ensure the quality of the reprocessing activities, CS concerning risk management should include minimum requirements for staff, premises and equipment.

Source: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj

2019-11

The European Commission has extended the call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices.

Interested candidates are invited to submit their application before 24 November 2019 through the following website:

https://ec.europa.eu/growth/content/call-expression-interest-expert-panels-medical-devices-and-vitro-diagnostic-medical-devices_en

An informative flyer you may find here: link

2019-11

At the moment there are 7 notified bodies designated to perform audits according the MDR. These notified bodies are: BSI-UK, BSI-NL, DARE!!, DEKRA Certification, IMQ and TÜV Rheinland, TÜV-SUD.

Under the IVDR, there are now 2 notified bodies designated. These notified bodies are: BSI-UK, DEKRA Certification.

We recommend staying in close contact with your Notified Body concerning their designation for the MDR and/or IVDR.

Source: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main

2019-11

The European Commission has announced that the publication of EUDAMED is delayed by 2 years. The Commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostic devices together in May 2022.

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

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