Do I need to get registered or have German entity to sell IVD products in Germany?

Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#3
Under the current IVD Directive, you do not have to register in Germany or have a German representative. Depending on where your company is based, you may need an authorised representative in EU.

When the IVD Regulation comes into force in 2022, the requirements for Importers and Distributor comes into effect. Given the additional requirements, I would start working on the new regulation now, if you haven't already done so.
 
Thread starter Similar threads Forum Replies Date
M Importing a Registered Class II Device, the Applying Our Label - Need New 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Does an Outside Steam Generator need to be Registered in the EU? EU Medical Device Regulations 2
I Does my company need to be ISO 13485 registered? ISO 13485:2016 - Medical Device Quality Management Systems 7
K Does a Radiotherapy device need a clinical trial for getting registered in China? ISO 13485:2016 - Medical Device Quality Management Systems 2
V Need to update to ISO 9001:2000, current registered to ISO 9002 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
W Need for current design or process control FMEA and Control Plans 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
S Need help with analysing a survey on minitab Using Minitab Software 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
G Need resources / tutorials about OPS (Operation) for ISO IT (Information Technology) Service Management 8
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
M AQL table - I need to sample 1250pcs AQL - Acceptable Quality Level 3
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
I IATF16949 Audit Preparation, Need "searchable" ANPQP 3.1 or latest IATF 16949 - Automotive Quality Systems Standard 1
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5

Similar threads

Top Bottom