Services

We offer consultations relating to the testing and approval of medical devices. Moreover, we support you with the creation of your CE documentation. Additionally, we register your products in national reimbursement systems or assist you in setting up a quality management system. Thanks to many years of experience and competent specialists, BEO BERLIN is able to accelerate the entry of your product into the health market. Every year we support over 250 product registrations in the medical technical aids register. Seminars on nursing science topics, medical device law and medical technical aids register (HMV) round off the service portfolio.

consulting

We can efficiently support you with the conformity assessment procedure according to MDD/MDR, the application for an HMV code and implementation of a QM system.

compiling

We can handle your regulatory requirements for you, including by preparing individual documents, evalluations, complete documentation or applications.

coordinating

We can assist you with required testing and case reports to ensure your verification procedure is fully recognised, from product testing to successful test report.

mdel

MDEL – Canada & Small Business Cost Reduction

Manufacturers holding a Medical Device Establishment Licence (MDEL) for Canada were contacted by Health Canada in December and the Annual Licence Review (ALR) Package was submitted with it.

Eudamed

EUDAMED – Actor Registration Module Operational Since December 1st, 2020

EUDAMED is the database developed by the European Commission for the registration of economic actors and their medical devices.

HMV Update of Product Groups 08, Insoles and 32, Therapeutic Activation Devices

The update of product group 08 insoles and product group 32 therapeutic activation devices was recently published.

BEO BERLIN Updates

Standards in Focus: DIN EN 62366 Usability According to Annex C

DIN EN 62366 Usability according to Annex C: A closer look at the standard to help manufactureres plan accordingly.

BEO BERLIN Updates

New Standards and Standard Projects in January 2021

DIN EN ISO 10651-5 (Project)
DIN EN ISO 11073-10101
DIN EN ISO 28399 (Draft)
DIN 33402-2
ISO 9241-971
DIN EN 10942 rev (Project)

France

Changes in the LPPR in 2021

Update: From July 2021 on a separate individual code must be requested for each aid in France.

MDR Certification Challenges Associated with Clinical Evidence

Interview by Michal Pallo (Department of Drug Design and Pharmacology, University of Copenhagen) with Michael Vent (BEO BERLIN) on the challenges for manufacturers associated with the new requirements for clinical evidence and evaluation under MDR.

HMV – What Role Does the G-BA Actually Play

Not all HMV (Hilfsmittelverzeichnis = medical technical aids registry) application procedures involve the G-BA, the Joint Federal Committee. Nevertheless, it plays an important role. The G-BA determines, within the framework…

BEO BERLIN

Swissmedic – Medical Devices in the Context of the Covid-19 Pandemic

Due to the unchecked spread of the new coronavirus (SARS-CoV-2) in many places, authorities and service providers in Switzerland continue to receive more and more questions about who is responsible…

Reprocessing of Single-use Products – Common Specifications

The implementing regulation (EU) 2020/1207 regarding common specifications for the reprocessing of single-use products was published in the Official Journal of the EU.  The Medical Device Regulation (MDR) provides for…