Over 1,000 notified body applications per month. Will your device be among them?

Do the math: Regulation 2023/607 The MDR was created under the assumption that manufacturers would be able to switch from the AIMDD and MDD to the MDR during their normal certification cycle. However, it took years before the first notified body was designated and the designation process is still ongoing, supporting structures, like EUDAMED, expert … Read more

Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices

This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more

Regulation 2023/607 MDR transitional arrangements for Class IIa and Class IIb, non-implantable devices

This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more

MDR Article 120 and 122 consolidated

Note: new text is in bold Article 120 Transitional provisions Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the … Read more

PRRC scenario

PRRC scenario, as posted on LinkedIn on 8 February 2023 According to MDCG Guidance 2021-25 on legacy medical devices, the PRRC is not required for legacy devices. With that in mind, a freshly appointed PRRC had a fairly easy job; the company was not MDR certified yet. With the current proposal of the European Commission … Read more

Feasibility check for the applicability of MDR Article 97

Expiring certificate At this moment AIMDD or MDD certificates may expire before a new MDR certificate is issued. In that case, a manufacturer may lose access to the EU market. MDCG 2022-18 provides guidance about how the Competent Authorities will handle the specific situation when a non-conformity is created by the expiration of a certificate … Read more

Quick due diligence checklist non-integral DDC

Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the … Read more

Quick due diligence checklist integral DDC

Pharmaceutical companies that work together with a medical device supplier for their integral drug-device combination need to have sufficient control over the readiness of the required documentation. Especially in the early stages of a project, these matters can be challenging. The checklist can provide an indication of the readiness of the documentation for the device … Read more

Drug-device combinations need a specific MD department within a pharma company

DDC There is a growing trend in the pharmaceutical field where we see companies not only develop their drug but also develop the device necessary to deliver the drug as intended. These drug-device combinations (DDC) come in various types and shapes: In some of these combinations, the device is considered to be a medical device … Read more

Case: Missed mixed status devices in a system

Incorporated IVD A multi-component device is intended to be used surgically invasive, where a specific intervention can be performed via a minimally invasive technique. During this operation, a sample can be taken and stored in a container for transfer to the lab. Sampling is optional, it is not the main objective of this intervention. When … Read more