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Partner & Associates

Contact

Contact our partners for additional services.

Klaas consulting is cooperating with medical device consultancy partners and associates in helping your firm to distribute your medical devices

mdi Europa GmbH acts as European Authorized Representative for a wide range of companies – from start-ups to established corporations throughout the world. Their highly qualified regulatory affairs experts have vast hands-on experience and have registered hundreds of medical device manufacturers for CE-marking with the European regulatory authorities. www.mdi-europa.com

BEO MedConsulting supports getting onto the reimbursement registers of „Medical Aids“ all over Europe, especially in Germany. Their experts can guide you and help with applications on behalf of your company to speed up this essential reimbursement process.
www.beoberlin.de

„Kanzlei am Aerztehaus“ focuses exclusively on medical law. They can provide you with comprehensive advice – judicially as well as from an economic point of view – covering all aspects adherent to the law of medicinal products and medical devices. In the past Dr. Kerstin Brixius was a legal consultant at the „German Federal Institute for Drugs and Medical Devices“. www.kanzlei-am-aerztehaus.de

„L.S. Marketing & Registration“  is a multidisciplinary medical devices consultancy. 20 years of in-depth experience& connections  in the Israeli medical devices market .1 Stop Shop for worldwide manufacturers for a smooth market entry in Israel. Its unique service – Israeli Registration Holder Services/Independent Israeli Independent RA Reps/ similar to EU Rep. Services. Registration from A-Z in the Israeli MOH  ,post- marketing follow up ,  allocation of distributors & import export services. Added value : Manufacturers stay independent. www.ls-amarandmore.com

MethodSense is a life science consulting firm guiding medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions into the US. MethodSense is the developer of InfoStrength Smart Enterprise Suite (SES), an enterprise document and business management software. InfoStrength SES is a Software as a Service (SaaS) application designed specifically for regulated businesses. www.methodsense.com

Be informed – latest news

Meet us in Duesseldorf or virtually 15-18 Nov. 21

Medica 2021 Duesseldorf

Latest Insights

  • 20. notified body according to MDR – Eurofins Expert Services Oy; they all are listed in the Nando database
  • the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
  • BfArM included the first “apps on prescription” in the new directory for digital health applications (DiGA) in early October 2020
  • new standalone UKCA mark after Brexit; current EU CE marking will still be in operation for Medical Devices and invitro diagnostic in Great Britain until June 2023
  • EU-implementation regulation for the reprocessing of disposable products, valid from 26 May 2021
  • FDA increases medical device registration fees from October 2020
  • The European Commission published the new “Clinical evaluation assessment report template” of the Medical Devices Coordination Group (MDCG) on 17 July 2020
  • On 1 July 20, the Swiss Federal Council adopted the revision of the Regulation on Medical Devices (MepV) and the new Regulation on Clinical Trials for Medical Devices (KlinV-Mep). As a result, Switzerland remains subject to EU medical device law.
  • In-vitro-diagsnostics must be re-evaluated according to the new IVDR by 26 May 2022.
  • In future, the IVDR will also cover high-risk products that are manufactured and used in a single health facility, as well as genetic screening and tests for predisposing patients
  • The European Council postpones the application of EUDAMED by two years until May 2022
  • the EU Council decided on 22 April 2020 that the EU MDR will be postponed until 26 May 2021 – read here!