CE Certification / PED Certification - Pressure Equipment

#1
We are new to selling in Europe. We are looking to sell in Germany. Thus, we need possibly a CE Marking and PED Certification.

The product are manholes for the top of tankers.

I have researched online and found limited information about PED Certification.

One site has six steps....

1) Product Classification
2) Risk Assessment
3) Conformity Procedure
4) Technical Documentation
5) EU Declaration Of Conformity
6) CE Marking

At this point, we are looking for information to do the product classification and conformity procedure.

Is there a good reference we could use to do the product classification and the conformity procedure? Or, do any of you have a step by step procedure?

Thanks in advance!!
 
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Leader
Super Moderator
#2
We are new to selling in Europe. We are looking to sell in Germany. Thus, we need possibly a CE Marking and PED Certification.

The product are manholes for the top of tankers.

I have researched online and found limited information about PED Certification.

One site has six steps....

1) Product Classification
2) Risk Assessment
3) Conformity Procedure
4) Technical Documentation
5) EU Declaration Of Conformity
6) CE Marking

At this point, we are looking for information to do the product classification and conformity procedure.

Is there a good reference we could use to do the product classification and the conformity procedure? Or, do any of you have a step by step procedure?

Thanks in advance!!
I was in the Pressure Equipment Directive world for a a few years but doing pressure relief valves - pretty different from your product.
What I can say is that if no one in your company knows the PED well, hire a consultant that specializes in that directive.
At least pay for an an initial consult to do a design review and tell you what level of CE mark you needs as there are several based on the product classification.
PED is a law so it's best not to mess around with guessing.
 

CharlieUK

Quite Involved in Discussions
#3
Completely agree with @ScottK - whilst forums such as this are useful tools for improving ones knowledge and seeking clarification to issues, for something as fundamental as learning compliance with PED (or some other Directives for that matter) from a standing start, it's not possible to learn enough to be sufficiently knowledgeable from a forum.
I wish you luck in improving your knowledge in this area.
 
#4
Thanks for your replies.

Yes, I understand I need to work with a notifying body to get the application done properly.

We are working with a notifying body.

My question is about the first step. That seems to be the issue that we are having.

I have been working with the notifying body on things when needed. And, I am completing the parts that I know that we need to complete. But, it is the classification step that our management is concerned. The notifying body consultant doesn't seem to understand the reason for the managements' pick of classification.

So, I'm trying to find someone who knows the first step well enough that we can properly classify our product.
 

ScottK

Not out of the crisis
Leader
Super Moderator
#5
Thanks for your replies.

Yes, I understand I need to work with a notifying body to get the application done properly.

We are working with a notifying body.

My question is about the first step. That seems to be the issue that we are having.

I have been working with the notifying body on things when needed. And, I am completing the parts that I know that we need to complete. But, it is the classification step that our management is concerned. The notifying body consultant doesn't seem to understand the reason for the managements' pick of classification.

So, I'm trying to find someone who knows the first step well enough that we can properly classify our product.
I'm saying work with a consultant in addition to your NOBO. They can help you classify your product and push back on the NOBO.
I doubt anyone on this forum has the specific knowledge of your product... we'd need to do a design review to really be able to advise on classification.
 
Thread starter Similar threads Forum Replies Date
T Who pays for certification to the PED (Pressure Equipment Directive)? Registrars and Notified Bodies 9
5 What is PED (Pressure Equipment Directive) Certification? CE Marking (Conformité Européene) / CB Scheme 5
K PED (Pressure Equipment Directive) Certification - We hold an ASME 'S' stamp CE Marking (Conformité Européene) / CB Scheme 11
Moncia Full system pre certification audit ISO 50001 Other ISO and International Standards and European Regulations 8
P RAC Certification Study group UK Medical Device Regulations 0
M BSI 13485 Lead Auditor Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
B AS9100 Certification Audit Accounting for Additional Customer QMS Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
A Applying for ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 8
K Device part of combination product certification requirements Medical Device and FDA Regulations and Standards News 3
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M Gravimetric blender for resin in automotive industry - periodical calibration via external lab with certification Reliability Analysis - Predictions, Testing and Standards 0
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
W Incoming Certification Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B Multisite Certification Requirements for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 8
PowerJunkie Cancelling AS9100 Certification - How and Who to notify? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H Regarding UL Certification CE Marking (Conformité Européene) / CB Scheme 6
Q ISO 13485 certificate needed if I go for MDSAP certification? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Eligibility for certification to IATF16949 IATF 16949 - Automotive Quality Systems Standard 8
M ASQ certification study material Professional Certifications and Degrees 1
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
D Is IATF certification required when customer doesn't require it? IATF 16949 - Automotive Quality Systems Standard 19
A Loss of certification because of outdated information in the Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 8
Sidney Vianna IAQG News Down with OPMT - Long live CERTIFICATION OVERSIGHT AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
H Relation of VDE mark with CE certification CE Marking (Conformité Européene) / CB Scheme 11
T Adding to certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Is NRTL certification mandatory in the US ? Registrars and Notified Bodies 2
H EAC-MED Certification CE Marking (Conformité Européene) / CB Scheme 0
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Attendance possibility for a certification audit ISO 13485:2016 - Medical Device Quality Management Systems 7
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
K SGS Certification - Advice on their Performance Service Industry Specific Topics 9
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N ISCC Plus - The international Sustainability Carbon Certification Sustainability, Green Initiatives and Ecology 2
S Which certification to get? Professional Certifications and Degrees 3
J Implementation, establishment and certification of IATF 16949. IATF 16949 - Automotive Quality Systems Standard 6
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 3
A MDR Article 16 Certification of Distributors by a Notified Body? EU Medical Device Regulations 8
T NDT/NDE Level 2 Technicians Certification Oil and Gas Industry Standards and Regulations 20
M PSE Certification Japan Medical Device Regulations 5
C IATF16949 certification eligibility IATF 16949 - Automotive Quality Systems Standard 6
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
H API monogram 4F - Certification process Oil and Gas Industry Standards and Regulations 2
J Recommendations for certification bodies ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom