Ref. Ares(2015)2251212 - 29/05/2015
Ref. Ares(2016)6183596 - 28/10/2016
EUROPEAN COMMISSION
Directorate-General for Trade
Directorate F - WTO, Legal Affairs and Trade in Goods
TRADE F.3 Tariff and Non–Tariff Negotiations, Rules of Origin
TTIP Meeting with MedTech and Cocir on Medical Devices
28/04/2015
Participants:
•
,
(DG TRADE);
,
(DG GROW)
•
,
,
(COCIR);
Summary:
On the 28th of April 2015, the European Commission met with MedTech and Cocir to discuss
the state of play of TTIP negotiations as well as the EU position paper on Medical Devices
published in the web on April 2015.
COM gave a brief summary on discussions and outcome of the TTIP 9th round.
COM noted that the position paper on medical devices resulted in some misunderstanding
regarding the mutual recognition of
Quality Management System audits (QMS).
Apparently US industry believes that the international pilot Medical Device Single Audit
Programme (MDSAP) is sufficient to avoid double inspections. COM noted that despite being
committed to MDSAP, a legal basis needs to be established for the EU to be able to accept
audit reports carried out by foreign inspectors. TTIP could provide for such legal basis.
Furthermore, COM explained that TTIP cannot provide for the acceptance of QMS audits
conducted under the authority of all the other different jurisdictions involved in MDSAP (e.g.
Canada, Australia, Brazil) given that it is a bilateral agreement.
COM noted also that the MDSAP pilot project does not provide for the legal certainty that
TTIP would provide for. Also should an MRA be negotiated between EU and US in this
matter, the number of EU Notified Bodies allowed to carry the single audit would have to be
increased on the basis of their competencies/accreditation (few NB are currently eligible
under the MDSAP pilot: 6 out of 14 eligible ones can be considered to be at an advanced
stage of the application –5 out of 6 and 12 out of 14 are European). Finally the scope of the
MRA would have to be discussed as currently US FDA accepts only routine/post market
inspections under the pilot MDSAP.
MedTech noted that the wording mutual recognition ('MRA') might be interpreted in such a
way that it goes beyond the framework of the MDSAP meaning any audit done by a notified
body in the EU or done by FDA would be recognised on either side.
COM noted that the EU legislation and legal constraints regarding acceptance of QMS audits
have to be explained to the US industry.
¾ It was agreed that the EU industry will liaise with the US industry
On
Unique Device Identification (UDI) system and database, COM explained that the EU IT
expert’s will study the technical dossier for the implementation of the UDI sent by the US and
will come back to the US FDA with questions if necessary. COM noted that while the EU is
committed to implement its UDI system, the adoption of the EU Regulation on Medical
Devices is needed preliminarily.
With regard to the
Regulated Product Submission (RPS), COM noted that no specific
discussions were held on this point. MedTech asked for clarification on the current pilots
conducted both at regional (EU) and at global (IMDRF) level. COM explained that the
regional pilot is supposed to focus on the low and medium risk level medical devices and
eventually it may feed into the global project.
Regarding the question on the
exchange of confidential information between EU Notified
Bodies/EU institutions and FDA COM clarified that all of the existing Confidential
Arrangements have already expired hence they need to be renewed in the future.
In relation to the point
on reinforce bilateral regulatory cooperation in new areas COM
explained that this area has not been discussed yet precisely but it would aim at providing
provision for reinforce cooperation between the regulatory authorities.