Armin Beck Anthony the requirements have changed for obl approval but the procedure is still valid regardless of the NB. Best Armin

The challenge or concern for industry is that the MDR will also require NB involvement for all device classes. How many hundreds if not thousands of companies in the UK alone will need to navigate the NB process and how are stretched NB's going to be able to find internal resources to conduct surveillance's or TF reviews?

As manufacturer of medical device my factory works with OBL issued by BSI (UK) NB 0086 for customer without problems. It is important the OBL has a complete technical file of medical device. With future new Regulations of MD (they will replace Directive 93/42/EEC) - the current OBLs will be inspected carefully by NB, the rules will be stricter.

Gianluca Mosca OBLs can still exist but, to explain in few words, they are compared -and assessed- as a "normal" manufacturer that outsourced the manufacturing of his product to a supplier (a critical subcontractor). They also undergo to unannounced audits (both "OBL" manufacturer and critical subcontractor).

Gianluca Mosca Anyway it is true that the "life" of the "ex OBL manufacturer" dramatically changed....

Anthony, this topic really deserves some discussion.
But, has there ever been an OBL procedure for CE marking?

I would say NO!
Try searching the text of the medical devices directive 93/42/EEC and you will not find this topic, the MDD only talks about Conformity Assessment Procedures (CAP) that every organization has to apply that CLAIMS to be the manufacturer (no matter if he is really producing the devices or not).

Yes, but there is this Guidance document EK-MED 3.9 B 16.
This document did NOT introduce a „simplified CAP for OBL“, it is a guidance for Notified Bodies.

No, the regulations have not been changed!
Otherwise we would have received a new EU directive modification and not just the COM REC 2013/473/EU reconfirming what was already stated in the MDD.

How is the situation on OBL outside the EU?
There is not a single country with a “simplified registration process” for OBL products.

Thanks for stepping into this topic Anthony.

Anthony: I think most companies are having issues. Should you require assistance feel free to reach out. Regards Ken

Anthony Molliex Thank you for your answer. However I know some NB that close totally the OBL activity... The others NB that keep this activity want almost the same technical files as those of the original manufacturer. What about confidentiality ?

Ronald Boumans Be aware that the MHRA has given their UK based notified bodies a preannouncement that they will soon introduce significant changes in the OBL certification process. MHRA will soon no longer accept subcontractors or suppliers fulfilling crucial obligations of manufacturers, which is in line with Commission Recommendation 2013/473/EU, Annex II, under "General advice in case of outsourcing of the production via subcontractors or suppliers". It is expected that from April 2017 it is required by UK based notified bodies to have full access to the technical file and have a quality system in place in which the OEM is integrated. This requirement is expected to end OBL manufacturing as we know it.
Notified Bodies in other Member States are likely to follow soon.

José E. Cabrera what changed? I have a client that was dropped by Intertek because they are not allowed to do any more OBL business...