Medical device CE marking

New IVD symbols for compliance with the IVDR

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

Common Specification for reprocessing of single use devices

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

Consolidated MDR now available (2020-04-24)

2020-05

The consolidated MDR is now available on the European Commission website.

 

Amended by:

Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020

 

Corrected by:

Corrigendum, OJ L 117, 3.5.2019, p.  9 (2017/745)

Corrigendum, OJ L 334, 27.12.2019, p.  165 (2017/745)

 

The consolidated MDR can be downloaded in our library

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424

Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices

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

Designated Notified Bodies for MDR and IVDR

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

MDCG: Software guidance

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

MDCG: Guide for Summary of safety and clinical performance

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

Guidance on symbols for MDR/IVDR labels

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/